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:

Affected Products 

  1. GROSHONG NXT, 4Fr CONNECTOR REPAIR KIT
  2. GROSHONG, BASIC TRAY WITH SHERLOCK STYLET, WITHOUT MICROINTRODUCER
  3. GROSHONG, BASIC TRAY WITH SHERLOCK STYLET AND MICROINTRODUCER
  4. SINGLE LUMEN, GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET, BASIC KIT
  5. SINGLE LUMEN, GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET, FULL KIT
  6. 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