FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management
FDA device recall Z-1620-2008 · posted 2008-08-06 · Terminated
Recall details
- Recalling firm
- Smith And Nephew, Inc. Wound Management Division
- 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.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- BTA
- Quantity affected
- 4796
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-03-31
- Date posted
- 2008-08-06
- Date terminated
- 2008-11-18
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERSATILE 1 WOUND VACUUM SYSTEM (K042134) | Blue Sky Medical Group Incorporated | 2004-11-01 |