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Power Injection Catheters with Guidewire (2014-07-08)
- Starting date:
- July 8, 2014
- Posting date:
- April 29, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53119
Recalled products
- POWERPICC SOLO CATHTER SL BASIC TRAY
- POWERPICC SOLO DL BASIC TRAY
- POWERPICC SOLO CATHETER TL BASIC TRAY
- POWERPICC SOLO BASIC TRAY WITH SHERLOCK
- POWERPICC SOLO2 WITH SHERLOCK STYLET
- POWERPICC CATHETER FULL TRAY
- POWERPICC SOLO2 CATHETER FULL TRAY
- POWERPICC SOLO2 FULL TRAY WITH SHERLOCK
Reason
Bard has notified customers of the potential for scalpel cut/stick injury following a change in the safety scalpel component in some bard peripherally inserted central catheter (PICC) kits. For users accustomed to the previous scalpel (bard-parker safety scalpel), a risk of improper use of the new safe-cut safety scalpel was noted. The customer letter described important differences in operation between the previous and current scalpel products.
Affected products
A. POWERPICC SOLO CATHTER SL BASIC TRAY
Lot or serial number
- REYF0123
Model or catalog number
- 3194118
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
B. POWERPICC SOLO DL BASIC TRAY
Lot or serial number
- REYF0223
Model or catalog number
- 3295118
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
C. POWERPICC SOLO CATHETER TL BASIC TRAY
Lot or serial number
- REYD0141
- REYD0327
- REYE1166
Model or catalog number
- 3396118
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
D. POWERPICC SOLO BASIC TRAY WITH SHERLOCK
Lot or serial number
- REYC1840
- REYD1001
- REYD2038
- REYE2261
- REYE2367
- REYF0240
Model or catalog number
- 9194118
- 9295118
- 9395118Q
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
E. POWERPICC SOLO2 WITH SHERLOCK STYLET
Lot or serial number
- REYC1881
- REYC1926
- REYD0126
- REYD0198
- REYD0312
- REYD0395
- REYD0396
- REYD1014
- REYD1015
- REYD1498
- REYD2021
- REYD2022
- REYD2066
- REYE0456
- REYE0457
- REYE1034
- REYE1795
- REYE1796
- REYE2228
- REYE2229
- REYF0115
- REYF0212
Model or catalog number
- 1194118
- 1295118
- 1396118
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
F. POWERPICC CATHETER FULL TRAY
Lot or serial number
- REYC1511
- REYC1530
- REYE0436
Model or catalog number
- 6174108
- 6275108
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
G. POWERPICC SOLO2 CATHETER FULL TRAY
Lot or serial number
- REYD0626
- REYE0582
- REYE0583
- REYE0722
- REYE1339
Model or catalog number
- 6194108
- 6295108
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
H. POWERPICC SOLO2 FULL TRAY WITH SHERLOCK
Lot or serial number
- REYC0797
- REYE0417
- REYE0562
- REYE1325
- REYE2142
- REYE2144
- REYE2184
- REYE2206
- REYE2312
- REYE2313
Model or catalog number
- 2194108
- 2195108
- 2295108
- 2396108
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES