Groshong Catheter Products (2021-04-08)
- Starting date:
- April 8, 2021
- Posting date:
- April 29, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75499
Last updated:
2021-04-29
Affected Products
- GROSHONG NXT, 4Fr CONNECTOR REPAIR KIT
- GROSHONG, BASIC TRAY WITH SHERLOCK STYLET, WITHOUT MICROINTRODUCER
- GROSHONG, BASIC TRAY WITH SHERLOCK STYLET AND MICROINTRODUCER
- SINGLE LUMEN, GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET, BASIC KIT
- SINGLE LUMEN, GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET, FULL KIT
- GROSHONG PERIPHALLY INSERTED CENTRAL CATHETER TRAYS
Reason
BD has identified two issues with the Groshong connector portion that impacts the Groshong product. First, the inner diameter of the distal connector may be reduced resulting in the inability to pass the catheter through the connector. Secondly, the catch slot on the distal connector may be deformed resulting in the inability for the distal connector to properly lock onto the associated proximal connector section.
Affected products
A. GROSHONG NXT, 4Fr CONNECTOR REPAIR KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
7812400
Companies
- Manufacturer
-
BARD ACCESS SYSTEMS, INC.
605 NORTH 5600 WEST
SALT LAKE CITY
84116
Utah
UNITED STATES
B. GROSHONG, BASIC TRAY WITH SHERLOCK STYLET, WITHOUT MICROINTRODUCER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
9617405
Companies
- Manufacturer
-
BARD ACCESS SYSTEMS, INC.
605 NORTH 5600 WEST
SALT LAKE CITY
84116
Utah
UNITED STATES
C. GROSHONG, BASIC TRAY WITH SHERLOCK STYLET AND MICROINTRODUCER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
9655405
Companies
- Manufacturer
-
BARD ACCESS SYSTEMS, INC.
605 NORTH 5600 WEST
SALT LAKE CITY
84116
Utah
UNITED STATES
D. SINGLE LUMEN, GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET, BASIC KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
91660417
Companies
- Manufacturer
-
BARD ACCESS SYSTEMS, INC.
605 NORTH 5600 WEST
SALT LAKE CITY
84116
Utah
UNITED STATES
E. SINGLE LUMEN, GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET, FULL KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CK000516
Companies
- Manufacturer
-
BARD ACCESS SYSTEMS, INC.
605 NORTH 5600 WEST
SALT LAKE CITY
84116
Utah
UNITED STATES
F. GROSHONG PERIPHALLY INSERTED CENTRAL CATHETER TRAYS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
7617405
7655405
Companies
- Manufacturer
-
BARD ACCESS SYSTEMS, INC.
605 NORTH 5600 WEST
SALT LAKE CITY
84116
Utah
UNITED STATES