Recall MonitorHealth Products
Hickman™ and Broviac™ Central Venous Catheter Kits
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular, Health products - Medical devices - General hospital and personal use
Product: Hickman™ and Broviac™ Central Venous Catheter Kits
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Hickman Dual-Lumen CV Catheter With SureCuff Tissue Ingrowth Cuff | More than 10 numbers, contact manufacturer. | 0600350 |
| Hickman Dual-Lumen CV Catheter With SureCuff Tissue Ingrowth Cuff | More than 10 numbers, contact manufacturer. | 0600570 |
| Hickman Dual-Lumen CV Catheter With SureCuff Tissue Ingrowth Cuff | More than 10 numbers, contact manufacturer. | 0600620 |
| Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff | HUKR0065 | 0600540 |
| Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff | HUKU0279 | 0600540 |
| Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff | HUKU0270 | 0600540 |
| Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff | HUKQ0535 | 0600650 |
| Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff | HUKU0311 | 0600560 |
| Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit With SureCuff Tissue Ingrowth Cuff | HUKS0776 | 0600560 |
Issue
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.