Medical Device Recall: Z-0018-2019

FDA Recalls dataset · Firm: COVIDIEN LLC · Status: Terminated

Recall Action Class: N/A Date Initiated: 2018-08-01 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0018-2019.

Recall Res Number
Z-0018-2019
Recalling Firm / Manufacturer
COVIDIEN LLC
FEI Number
1282497
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2018-08-01
Date Posted
N/A
Date Terminated
2020-06-03
Product Code
NAD
Event Number
80924
Product Quantity
2,730,821 units in total
Product Description 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.
Reason for Recall Potential for product sterility breach due to a compromised or pinched seal defect
Action Details 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.
Distribution Pattern US Nationwide Distribution
Code Information / Serial Numbers 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

Related Establishments / Registrations

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