Recall Z-1620-2008 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
Smith And Nephew, Inc. Wound Management Division
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.
| Date | Aug 6, 2008 (initiated Mar 31, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling mix-ups |
| 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. |
| Quantity | 4796 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042134 | VERSATILE 1 WOUND VACUUM SYSTEM Blue Sky Medical Group Incorporated, Nov 1, 2004 |