Recall Z-0018-2019
Covidien LLC · initiated August 1, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Codes / lots: Lot Numbers: 18D180762,18D180862,18E029062,18E029162,18E029262, 18E029362,18E070662,18E070462,18E070562,18E130962, 18E131062,18E166462,18E166562,18E131162,18E222562, 18E222462,18F034562,18F034462,18F034362,18F072562, 18F072462,18F122462,18F122362
Reason for recall
Potential for product sterility breach due to a compromised or pinched seal defect
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0018-2019
- Initiated
- August 1, 2018
- Terminated
- June 3, 2020
- Product code
- NAD – Dressing, Wound, Occlusive
- Quantity
- 2,730,821 units in total
- Distribution
- US Nationwide Distribution
- Recalling firm
- Covidien LLC, Mansfield, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0013-2019 Class II | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332…Potential for product sterility breach due to a compromised or pinched seal defect | 08/01/2018Terminated |
| Z-0014-2019 Class II | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF…Potential for product sterility breach due to a compromised or pinched seal defect | 08/01/2018Terminated |
| Z-0015-2019 Class II | Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880…Potential for product sterility breach due to a compromised or pinched seal defect | 08/01/2018Terminated |
| Z-0016-2019 Class II | Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716…Potential for product sterility breach due to a compromised or pinched seal defect | 08/01/2018Terminated |
| Z-0017-2019 Class II | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product…Potential for product sterility breach due to a compromised or pinched seal defect | 08/01/2018Terminated |