JUNE
2001
PRODUCT:
a)
Coordinate Knee Cemented Stem, Ref 1968-01-000, all lots.
Coordinate
Knee Cemented Stem, Ref 1968-02-000, all lots.
Coordinate
Knee Cemented Stem, Ref 1968-03-000, all lots.
b)
Coordinate Knee-Fluted Stem, Ref , 1968-11-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1969-12-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-13-000, all
lots.
Coordinate
Knee-Fluted Stem, Ref 1968-14-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-15-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-16-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-17-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-18-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-19-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-20-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-30-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-31-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-32-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-33-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-34-000, all lots.
Coordinate
Knee-Fluted Stem, Ref 1968-35-000, all lots.
c)
Coordinate Ultra Knee Cemented Stem, Ref 1884-21-000, all lots.
Coordinate
Ultra Knee Cemented Stem w/Taper, Ref 1884-21-500, all lots.
Coordinate
Ultra Knee Cemented Stem, Ref 1884-22-000, all lots.
Coordinate
Ultra Knee Cemented Stem, Ref 1884-23-000, all lots.
d)
Coordinate Ultra Knee-Fluted Stem, Ref 1884-31-000, all lots.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-32-000, all lots excluding lots VJ7J41 and
T5VAMA.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-33-000, all lots excluding lots VJ4EV1 and
VD4A7A.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-34-000, all lots excluding lot VJ7JV1.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-35-000, all lots excluding lots VJ4CF1 and
VC4NMA.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-36-000, all lots excluding lots VJ4CE1 and
VJ4CD1.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-37-000, all lots excluding lots VJ4ES1 and
VJ4EM1.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-38-000, all lots excluding lot VJ7KD1.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-39-000, all lots excluding lot VJ7JW1.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-40-000, all lots excluding lot T37K5A.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-41-000, all lots.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-42-000, all lots.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-42-000, all lots excluding lots VJ4EW1,
VJ4EWA, U86BLA and U86BLB.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-43-000, all lots excluding lot VD4A8A.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-44-000, all lots.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-45-000, all lots excluding lots VJ4CC1,
VJ4CCA, VJ4CB1 and VJ4CA1.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-46-000, all lots, excluding lot VJ7JX1.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-50-000, all lots.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-51-000, all lots.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-80-000, all lots.
Coordinate
Ultra Knee-Fluted Stem, Ref 1884-81-000, all lots.
MANUFACTURER: DePuy Orthopaedics, Warsaw, Indiana.
DISTRIBUTION: United States, Brazil, Canada and England.
QUANTITY: 1700.
REASON: There is a possibility for sterility to be
compromised due to packaging failure under routine shipping conditions.
PRODUCT: Access (beta) hCG Reagent Packs
CODES: Part No. 33500, Lot Nos. 007754 and 007755.
MANUFACTURER: Beckman Coulter, Inc., Brea, CA.
DISTRIBUTION: Nationwide, Puerto Rico, Argentina, Australia, Canada, Germany,
Japan, South Africa, PR China, Brazil, Korea, and France.
QUANTITY: 2445.
REASON: Low results were obtained with level 1 Quality
Control material.
PRODUCT: a) Stryker MedSurg Bed;
b) Stryker MedSurg Bed
CODE: a) Model
No. 3000; b) Model No. 3002.
MANUFACTURER: Stryker Corporation, Kalamazoo, MI.
DISTRIBUTION: United States, Canada, China and Kuwait.
QUANTITY: 2323 units.
REASON: The weight readout for the bed exit system may be
inaccurate, and the patient exit system may not alarm.
PRODUCT: CardiAssist External Counter Pulsation (ECP) System
CODE: All codes.
MANUFACTURER: Cardiomedics, Inc., Irvine, CA.
DISTRIBUTION: Nationwide and Israel.
QUANTITY: 62
REASON: When two patients are hooked up at the same time
on the unit the device pumps one patient based on the other patient's ECG
signal.
PRODUCT: CardiAssist External Counter Pulsation (ECP)System
CODES: n/a
MANUFACTURER: Cardiomedics, Inc., Irvine, CA.
DISTRIBUTION: Nationwide and Israel.
QUANTITY: 36
REASON: The screen on the unit containing software version
1.4.3 intermittently locks up. Unexpected shutdown; deletion of use for
cardiogenic shock.
PRODUCT: Clip Applier Handle
CODES: Model No. CA020; Model No. CA040.
MANUFACTURER: Applied Medical Resources, Rancho Santa
Margarita, CA.
DISTRIBUTION: Nationwide.
QUANTITY: 7,989.
REASON: There is a potential for inadequate clip
retention.
PRODUCT: Creatine Kinase (CK/NAC) R2 Reagent (see below).
CODES: Catalog No. 1126006, Lot Nos. 143139, 143151, 143219,
143255; Catalog No. 1928929, Lot Nos. 61439901, and 61547401.
MANUFACTURER: Roche Diagnostics Corp., Indianapolis,
IN.
DISTRIBUTION: United States and Switzerland.
QUANTITY: 1000 kits.
REASON: Crystals forming in these lots can lead to erroneous
low patient results due to clogging of the reagent tubing.
PRODUCT: ACL Futura Coagulation Analyzers
CODES: All Serial Numbers with software version below
V3.4.
MANUFACTURER: Instrumentation Laboratory Co., Lexington,
MA.
DISTRIBUTION: Nationwide
QUANTITY: 345.
REASON: There is a software error that may cause index
file and record information to be mismatched.
PRODUCT: Cuffless Adult Tracheostomy Tube
CODE: Catalog No. 60A180, Lot No. 909590.
MANUFACTURER: Bivona Medical Technologies, Div. UroQuest
Medical Corp., Gary, IN.
DISTRIBUTION: United States, France and Sweden.
QUANTITY: 90.
REASON: Device misbranded due to the container and box was
labeled an 8.0 O.D., but the neckplate on the tube was 9.0 O.D.
PRODUCT: Cuffless Adult Tracheostomy Tube
CODE: Catalog No. 90A170, Lot No. 966360.
MANUFACTURER: Bivona Medical Technologies, Div. UroQuest
Medical Corp., Gary, IN.
DISTRIBUTION: United States, Canada, Denmark, Sweden and
Taiwan.
QUANTITY: 97.
REASON: One of the sealed trays is empty.
WEEK ENDING JUNE 16
PRODUCT: Single Use Staplers as follows:
a)
AutoSuture Endo GIA* II 60mm 2.5mm Order Code: 030412.
b)
AutoSuture Endo GIA* II 60mm 3.5mm Order Code: 030414.
CODE: a) Lot Numbers: N0M171,
N0M252, N0M306, N1A107, N1A200, N1A286, N1B12, N1B105, N1C07, N1C65, N1C116
Order Code 030414
b) Lot Numbers: N0M250, N0M259, N0M260, N1A155,
N1A18, N1A197, N1A224, N1A238, N1A239, N1A287, N1A333, N1A352, N1A82, N1A96,
N1B157, N1B167, N1B211, N1B257, N1B284, N1B35, N1B86, N1C130, N1C35, N1C66
MANUFACTURER: United States Surgical
Corp., North Haven, CT.
DISTRIBUTION: Nationwide, Canada, Japan,
Brasil, Korea, France, Mexico, Columbia, Chile, New Zealand, Austria, and
Switzerland. VA Medical Centers: Houston, TX, Richmond, VA
QUANTITY: 36,370 units.
REASON: The units may transect
without all of the staples being placed into the tissue.
PRODUCT: a) Cryovalve Allograft b) Cryovalve Allograft
CODE: a) Model No. AVOO, Serial
No. 6087906; b) Model No. PVOO, Serial
No. 6087914.
MANUFACTURER: Cryolife, Inc., Kennesaw,
GA.
DISTRIBUTION: Reno, NV and Omaha, NE
QUANTITY: 2 units.
REASON: The donor did not meet the
current guidelines regarding serodilution of plasma because of the amount of
transfused/infused fluids administered.
PRODUCT: a) Philips
Tomoscan M.; b) Philips Tomoscan EG.;
c) Philips Tomoscan EG.
CODE: a) Philips Tomoscan M; b) Philips Tomoscan EG;
c) Philips Tomoscan EG Compact.
MANUFACTURER: Analogic Corportation,
Peabody, MA.
DISTRIBUTION: U.S. and worldwide.
QUANTITY: 48 units in the US, 367
units Worldwide.
REASON: The diagnostic x-ray
devices fail to conform to design specifications relating to the accomplishment
of their intended purpose.
PRODUCT: a) DePuy
Acclaim Total Elbow System Humeral 100 MM Component.
b) DePuy
Acclaim Total Elbow System Bobbin Component.
CODE: a) Catalog No. 1722-11-990, Lot Nos. U37B21 and
UX4JJ1; b) Catalog No. 1722-50-990, Lot
No. U1TFE1.
MANUFACTURER: DePuy Orthopaedics,
Warsaw, IN.
DISTRIBUTION: California, Colorado,
Massachusetts, Mississippi, Rhode Island and England.
QUANTITY: 23
REASON: An incorrect taper angle
was used during manufacture.
PRODUCT: Breathing Circuits (see below);
a) King
Systems brand Jackson-Rees Modification Breathing Circuits.
b) King Systems
brand Mapleson D Breathing Circuit.
c) Ped F2
Pediatric Anesthesia Breathing Circuit.
d) Norman
Elbow, individually packed [VETERINARY
DEVICE]: Anesco brand Mapleson C
Breathing Circuits.
CODE: I. King Systems brand Jackson-Rees Modification breathing circuits, as
follows:
A. Ref
# 2-60775; Lots I2CN2, I2EH6, I2I15,
I2LL3 and I2NX0;
B. Ref
# 370; lots I27U1, I2H13, I2JS4 and I2NN0;
C. Ref
# 3700; lots I28Z3, I2DM0 and I2JY6;
D. Ref
# 3701; lots I2757, I29U8, I2AV3, I2DV0, I2GG3, I2J64 and I2MB2;
E. Ref
# 3702; lot I2F31;
F. Ref
# 3703-375; lots I28M3, I2CD1, I2G40, I2MB3 and I2MB3;
G. Ref
# 37072-WSLN; lot I2GG4;
H. Ref
# 37237; lot I2JH1;
I. Ref
# 3731-366WS; lots I2BK5, I2DC5, I2F32, I2IF4 and I2MM3;
J. Ref
# 374; lots I2DC6, I2EJ4, I2GT4, I2H61, I2IF5 and I2K79;
K. Ref
# 374Z; lots I2EQ7, I2F33, I2GG6, I2IF6 and I2L94;
L. Ref
# 3741; lots I2758, I2847, I2AV4, I2EJ5, I2HP8, I2IS8, I2K80, I2MX2 and I2DM1;
M. Ref
# 3741-WSNZ; lots I28M4, I2D11 and I2MX3;
N. Ref
# 3742; lots I2A61, I2J65, I2KV3, I2PG7, 128M5 and 12MX4;
O. Ref
# 3743, lots I2IS9 and I2MX5;
P. Ref
# 3743-321WS; lots I28Z4, I2C03, I2GG5 and I2J66;
Q. Ref
# 3743-6031; lot I2557;
R. Ref
# 3743-WSN; lots I2CD2 and I2G41;
S. Ref
# 3745; lot I2MX6;
T. Ref
# 3771; lots I2D12, I2EJ6, I2GG7, I2KV4, I2N95 and I2DM2;
U. Ref
# 3771-WSN; lots I2558, I26I6, I27I4, I27U2, I2B33, I2CP7, I2E60 and I2FV6;
V. Ref
# 3771Z; lot I2HI4;
W. Ref
# 3772; lot I2MB4;
X. Ref
# 3772-WSN; lots I2559, I26I7, I2B34, I2CP8, I2E61, I2FV7, I2IF7, I2JS5 and
I2L95;
Y. Ref
# 3773-WSN; lot I28M6;
Z. Ref
# 3775; lots I2DM3 and I2LN6;
AA. Ref
# 3775-WS; lot I2848;
AB. Ref
# 6072442P; lots I2FH3 and I2IH4;
AC. Ref
# 60740; lots I29V7, I2AW5, I2CE1, I2EL1, I2GI0, I2JH6, I2LP4 and I2PH0;
AD. Ref
# 60742; lots I26U5, I2906, I29V8, I2AW6, I2GI1, I2MY8 and I2PS0;
AE. Ref
# 60743; lots I28N2, I2AW7, I2DD7, I2F39, I2HF3, I2JH7 and I2MD1;
AF. Ref
# 60771; lots I2649, I2E69 and I2G12;
AG. Ref
# 60772; lots I2IH5 and I2MD2;
AH. Ref
# 60773; lots I2767, I29J5, I2F93, I2JH8, I2LA1 and I2MD3;
AI. Ref
# 61740; lot I2KA0;
AJ. Ref
# 61743; lots I2CQ9, I2EL2 and I2JS9;
AK. Ref
# 61750; lots I26J3, I27J9, I29V9, I2BC0, I2CR0, I2EL3, I2GW6, I2IH6, I2JT0,
I2LA3 and I2Q33;
AL. Ref
# 61772; lots I26U6, I27K0, I2BL1 and I2HF4;
AM. Ref
# 61773; lots I27K1, I2B42, I2E70, I2FW6, I2HF5, I2JT1 and I2LA4;
AN. Ref
# FGL3740; lots I2DP6 and I2G91.
II. King
Systems brand Mapleson D breathing circuits, as follows:
A. Ref
# 4710-101; lot I2GT5;
B. Ref
# 4740; lots I2B39 and I2JH2;
C. Ref
# 4741; lots I29E1 and I2CQ3;
D. Ref
# 4760; lot I28M8;
E. Ref
# 4762; lots I28Z9, I2BL0, I2H64 and I2N99.
III. Ped
F2 Pediatric Anesthesia Breathing Circuit, Ref # F90542; lot I2A06.
IV. Norman
elbow, individually packaged, Ref # 838-052-100P; lot I28Q1.
V. [VETERINARY
DEVICE]: Anesco brand Mapleson C
breathing circuits, Ref # A1003; lot I2H29.
ANESCO, P.O. Box 492, Georgetown, Kentucky.
MANUFACTURER: King Systems Corporation,
Noblesville, IN.
DISTRIBUTION: United States, Canada,
Japan and Mexico.
QUANTITY: 21,680
REASON: There is a possible
obstruction of the fresh gas inlet of the elbow.
PRODUCT: NexGen Knee Threaded Fixation Pin
CODE: Catalog No.
00-5978-013-00, Lot Nos. 71350300, 71915000.
MANUFACTURER: Zimmer, Inc., Warsaw, IN.
DISTRIBUTION: United States, Australia,
Belgium, Canada Germany, Italy, Japan and the United Kingdom.
QUANTITY: 708
REASON: The hex end of the pin is
incorrect and will not assemble with the driver to secure the Micro-Mill
femoral mounting base instrumentation to the surgical site.
PRODUCT:
a) 1000464
5F AtheroCath Bantam Atherectomy Catheter.
b) 1000465
6F AtheroCath Bantam Atherectomy Catheter.
c)
1000466 7F AtheroCath Bantam
Atherectomy Catheter;
d) 20344-01
5mm 6F AtheroCath SCA-EX Atherectomy Catheter.
e) 20345-01
5mm 7F AtheroCath SCA-EX Shortcutter Atherectomy Catheter.
f) 20354-01
6F AtheroCath GTO Atherectomy Catheter.
g) 20355-01
7F AtheroCath GTO Atherectomy Catheter.
h) 20361-01 7FG SCA-EX (Graft) AtheroCath
Atherectomy Catheter.
CODE: All codes.
MANUFACTURER: Guidant Corporation,
Temecula, CA.
DISTRIBUTION: Japan
QUANTITY: 829 units.
REASON: Tip of artherectomy
catheter dislodged in a patient during procedure.
WEEK ENDING JUNE 30
PRODUCT: X-ray Tables
CODES: XRT 600 R/F.
MANUFACTURER: Imago Radiology, Abbiategrosso, Italy.
RECALLED BY: Wuestec Medical, Inc., Mobile, AL
DISTRIBUTION: Nationwide.
QUANTITY: 2 units.
REASON: The
units fail to comply with performance standards (21 CFR 1003.2) with regard to:
importation, establishing and maintaining manufacturing records and finished
device records, no product report submitted and an inadequate certification
program.
PRODUCT: Veterinary surgical CO2 laser systems.
CODE: a)
ML015-CA; b) ML025-CA.
MANUFACTURER: Millennium Medical Systems, Inc., Aurora,
IL.
DISTRIBUTION: AZ, MI, OH, TX and WI.
QUANTITY: 5 units.
REASON: Lacked certification and identification labels and
instructional and promotional materials contained implied claims for human use.
PRODUCT: Television Product.
CODE: a)
SME-34WHD5; b) SME-32HD5;
c) SME-27HD5.
MANUFACTURER: Sampo Corporation, Baldwin Park, CA.
DISTRIBUTION: Nationwide.
QUANTITY: 537 total units.
59 units
of model SME-34WHD5 sold in U.S.
33
units of model SME-32HD5 sold in U.S.
305
units of model SME-34WHD5 in inventory in U.S.
120
units of model SME-32HD5 in inventory in U.S.
20
units of model SME-27HD5 in inventory in U.S.
REASON: X-radiation exceeded the 0.5 mr/hr exposure rate
limit.
PRODUCT: a) Roche Cobas Integra 700
Analyzers with a Hewlett-Packard 71 Monitor; b) Roche PSD 1 (Primary Sample
Distribution System) with a Hewlett-Packard 71 Monitor
CODES: a) Model
No. D8903A, Component, Integra 700 Catalog Number is 1044826; b) Model No.
D8903A, Component, PSD 1 Catalog Number is 1806076.
MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.
DISTRIBUTION: Nationwide.
QUANTITY: 113 units.
REASON: The monitor of the device can result in an
electric shock to anyone contacting a certain area on the top of the monitor.
PRODUCT: FlexiLab Laboratory Information System
CODE: FlexiLabÆ versions 5.2, 5.23, and 5.3.
MANUFACTURER: Sunquest Information Systems, Inc., Tucson,
AZ.
DISTRIBUTION: Nationwide, United Kingdom, Ireland,
Canada, Denmark and Saudi Arabia.
QUANTITY: 456
REASON: Using devices with these software versions with
roll and scroll differential keyboard may miscalculate the absolute blood cell
counts.
PRODUCT: BD Vacutainer Whole Blood Tube with K3 EDTA
CODES: Lot No. 0185744.
MANUFACTURER: Becton Dickinson, Franklin Lakes, NJ.
DISTRIBUTION: Nationwide and Japan, Argentina and Canada.
QUANTITY: 1,043,000 tubes.
REASON: An incorrect volume of additive was dispensed into
the tubes, causing blood specimen to clot.
PRODUCT: Ring-Loc Brand Ring Loc Acetabular Liner
CODES: 32 MM/10 Degree, size 24, Arcom UHMWPE.
MANUFACTURER: Biomet Manufacturing, Inc., Warsaw, IN.
DISTRIBUTION: Nationwide and Australia.
QUANTITY: 19
REASON: Device misbranded in that the inner sphere
diameter of the product measures 28mm not 32mm as indicated on the labeling.
PRODUCT & CODE:
Ventak
Prism Automatic Implantable Cardioverter Defibrillators Ventak Prizm VR Model
No. 1850, Serial Nos. 103440-103442, 103447-
103470,
103472-103473, 103475, 103479-103515, 103517-103847, 103849- 103880,
103882-104235, 104237-104883, 104885-104886, 104888, 104891-
105008,
105010-105949, 105951-106009, 106012-109299, 109301-109303, 109305-109845;
Ventak
Prizm DR Model No. 1851, Serial Nos. 307946, 307972, 307976, 307988,
307995-308002, 308006-308007, 308009, 308011, 308016, 308019-
308020,
308026-308028, 308030-308047, 308054, 308069-308075, 308077-308115,
308118-308146, 308148-308155, 308158-308269, 308271-308285,
308288-308309,
308311-308320, 308322-308326, 308328-308388, 308390-308406, 388408-308431,
308433-308434, 308436-308437, 308439-308665,
308667-308699,
308701-308713, 308715-308747, 308749-308790, 308792-308825, 308827-388970,
308972-308989, 308991, 308993-309294, 309296-
309509,
309511-309842, 309844-310083, 310085-310095, 310098-310101, 310104-310105,
310108-310111, 310128-310175, 310177-310222, 310224-
310225,
310227-310248, 310251-310307, 310309-310329, 310335-310337, 310341-310387,
310389-310409, 310411-310943, 310945-311423, 311425-
312590,
312592-312815, 312817-313201, 313203-314612;
Ventak
Prizm VR HE Model No. 1852, Serial Nos. 100000-100507;
Ventak
Prizm DR HE Model No. 1853, Serial Nos. 300005-300011, 300013-300014, 300017,
300019-300020, 300022, 300031-300033, 300035, 300037-300038, 300045-300063,
300065-300066, 300068-300150, 300152, 300154-300280, 300282-300286,
300288-300317. 300319-300324, 300326-301611;
Ventak
Prizm VR HE Model No. 1857, Serial No. 500000-500123;
Ventak
Prizm DR HE Model No. 1858, Serial No. 600000-600129.
MANUFACTURER: Guidant Corp., St. Paul, MN.
DISTRIBUTION: Nationwide and worldwide.
QUANTITY: 13,833
REASON: Devices switch to the Safety Mode which limits
available shock therapy.
PRODUCT: a) Cryovalve Allograft Heart Valve; b) Cryovalve Allograft Heart Valve
CODE: a) Model No. PV00, Serial No. 6127401; b) Model
No. AV00, Serial No. 6127428.
MANUFACTURER: Cryolife, Inc., Kennesaw, GA.
DISTRIBUTION: Ottawa, Canada and New Orleans, LA.
QUANTITY: 2 units.
REASON: The donor did not meet current guidelines
regarding serodilution of plasma because of the amount of transfused/infused
fluids administered.
PRODUCT: Mavig Portegra Ceiling Suspension System, used with lead shields and
injectors This recall includes all model numbers of shields and injectorsThe
following model numbers/descriptions:
PT
6262 - 30 x 40 cm - lead glass shield, 1.5 mm lead equivalent.
PT
6272: Lead acrylic shield, 61 x 76 cm (24 x 30 in.) 0.5 mm lead equivalent.
PT
6272B71: Injector arms
PT
6272B72LF: Injector arms
Model
6272SHB: Side-mounted lead acrylic shield with patient cutout, 61 x 76 cm (24 x
30 in.), 0.5 mm lead equivalent;
Model
PT 6274: Smaller size lead acylic shield, 40 x 50 cm (16 x 20 in.), 0.5 mm lead
equivalent;
Model
PT 6290: Large size lead acrylic shield with patient contour cutout, 61 x 76 cm
(24x30 in.), 0.5 mm lead equivalent;
Model
PT6290SHB: Same as PT6272SHB except with ceiling track from Model PT 6290;
Model
PT 6294: Lead Acrylic Shield, 40 x 50 cm (16 x 20 in.), 0.5 mm lead equivalent.
CODE: The recall involves ALL MODEL numbers of shields
and injectors:
Model
Numbers / related spring arm subpart numbers;
PT6262
(30 x 40 cm) / PT6272B53 or OT25U11 or
OT25U04
PT6262
(40 x 50 cm) / PT6272B54 or OT25U10 or
OT25U11
PT6262
35 x 76 / PT6272B55 or OT30U03
PT6272 /
PT6272B50 or OT25U01
PT6272SHB /
PT6272B50 or OT25U01
PT6274 / PT6272B51 or OT25U02
PT6290 /
PT6272B50 or OT25U01
PT6290SHB /
PT6272B50 or OT25U01
PT6294 / PT6272B51
or OT25U02
Injector
arm model numbers: PT6272B71 /
PT6272B71 or GD4OU30
PT6272B72LF
MANUFACTURER: MAVIG GmbH, Munich, Germany.
RECALLED BY: Protec, Pittsford, NY
DISTRIBUTION: Nationwide.
QUANTITY: 1,284 units.
REASON: The spring arm may break when used with shield and
injector attachments.
PRODUCT: Encision AEM Fixed-Tip J-Hook Electrode, 5mm, Reusable, Catalog No.
ES3510B,
CODE: Lot No's: EH, EL, FB.
MANUFACTURER: Encision Inc., Boulder, CO.
DISTRIBUTION: Nationwide and Canada.
QUANTITY: 171 units.
REASON: J-hook electrode tip could break off during use.