CanadaHickman™ and Broviac™ central venous catheter kits from Bard Access Systems are affected; they can be identified by product names and model/catalogue numbers 0600350, 0600570, 0600620, 0600540, 0600650, 0600560 and listed lot/serial numbers including HUKR0065, HUKU0279, HUKU0270, HUKQ0535, HUKU0311, HUKS0776 (some Hickman listings note “More than 10 numbers, contact manufacturer”). The outer tray packaging may be damaged, potentially compromising the sterile barrier and the sterility of the inner tray surface and instructions for use. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Bard Access Systems, Inc., 605 North 5600 West, Salt Lake City, Utah, United States, 84116.
How to identify it
Affected products: Hickman Dual-Lumen CV Catheter With SureCuff Tissue Ingrowth Cuff; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0600350
Affected products: Hickman Dual-Lumen CV Catheter With SureCuff Tissue Ingrowth Cuff; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0600570
Affected products: Hickman Dual-Lumen CV Catheter With SureCuff Tissue Ingrowth Cuff; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0600620
Affected products: Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff; Lot or serial number: HUKR0065; Model or catalogue number: 0600540
Affected products: Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff; Lot or serial number: HUKU0279; Model or catalogue number: 0600540
Affected products: Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff; Lot or serial number: HUKU0270; Model or catalogue number: 0600540
Affected products: Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff; Lot or serial number: HUKQ0535; Model or catalogue number: 0600650
Affected products: Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff; Lot or serial number: HUKU0311; Model or catalogue number: 0600560
Affected products: Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff; Lot or serial number: HUKS0776; Model or catalogue number: 0600560
The hazard
BD has identified via internal inspections that the packaging of some Hickman catheter and Broviac catheter kits may have damage present on the outer tray, potentially compromising the sterile barrier. This product features a double-tray packaging structure (outer tray and inner tray). The inner tray, which contains the catheter and accessories, is sealed inside the outer tray along with the instructions for use. The sterility of the outer surface of the inner tray and the instructions for use may be compromised.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States