Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Recall
- Recall Number
- Z-0015-2019
- Event Number
- 80924
- Firm
- COVIDIEN LLC
- FEI Number
- 1282497
- Product Code
- NAD
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 1, 2018
- Terminated
- June 3, 2020
- Address
- 15 Hampshire St, Mansfield, MA, 02048-1113
Description
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Potential for product sterility breach due to a compromised or pinched seal defect
On August 1, 2018 Cardinal Health issued Urgent Medical Device Recall notices to U.S. customers via Fed Ex and OUS customers were directly contacted by Quality & Regulatory Affair representatives supporting that country. Customers were advised to take the following actions: 1. Inspect stock and quarantine affected product. 2. Immediately stop using affected product. 3. Return the completed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from customers, and to prevent further notices. 4. Notify any customers to whom you may have distributed product affected by this recall. 5. Contact the appropriate Customer Service group to arrange for credit and return of any affected product you may have: Hospital 800-964-5227 Federal Government 800-444-1166 Distributors800-635-6021 All other customers 888-444-5440 Customers with any questions regarding this letter may call (800) 292-9332.
US Nationwide Distribution
2,730,821 units in total