Recall Z-1620-2008
Smith And Nephew, Inc. Wound Management Division · initiated March 31, 2008
Product
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.
Codes / lots: Lot numbers: 517141, 517269, 517143, and 517108
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.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-1620-2008
- Initiated
- March 31, 2008
- Posted by FDA
- August 6, 2008
- Terminated
- November 18, 2008
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Quantity
- 4796
- Distribution
- Nationwide Distribution.
- Recalling firm
- Smith And Nephew, Inc. Wound Management Division, Largo, FL