FDA Device Recall Z-0016-04: Smith And Nephew, Inc. Wound Management Division

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0016-04.

Recall Res Number

Z-0016-04

Recalling Firm / Manufacturer

Smith And Nephew, Inc. Wound Management Division

FEI Number

3006760724

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2003-04-15

Date Posted

2003-10-15

Date Terminated

2012-07-11

Product Code

N/A

Event Number

26318

Product Quantity

3355

Product Description Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773

Reason for Recall Product may not meet the established stability specification before the end of labeled expiry date.

Action Details A Recall notification with a Response Form was mailed first class with return reciept requested on April 15, 2003 to direct accounts. The recall was to the wholesale distributor level only. The accounts were asked to check their stock immediately and to return recalled product to the Recalling Firm in Largo, FL. Non responding accounts were sent follow-up Recall Notifications letters.

Distribution Pattern The recalled devices were distributed to 81 direct wholesalers or medical facilities nationwide. There were no direct international or government/military accounts.

Code Information / Serial Numbers 021022A, 021023A, 021118A, 030106A, 030107A

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Medical Device Recall: Z-0016-04

Recall Parameters & Description

Public Record Disclaimer