FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product. Indicated for patients who wold benefit from a suction device particularly as the device may promote wound healing.
FDA Recall Z-1620-2008 · Posted 2008-08-06
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Recalling FirmSmith And Nephew, Inc. Wound Management Division
Recall StatusTerminated
Product CodeBTA
Date Initiated2008-03-31
Date Terminated2008-11-18
Product Quantity4796
Reason for Recall
Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.
Firm Action
Consignees were notified of recall by letter (Correction and Removal Notification) sent to customers on 3/31/08. They were asked to check their stocks, identify, and return all affected units to Smith & Nephew according to the instructions. Consignees are to contact the Customer Care Center at 1-800-876-1261, if they have additional questions.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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