Recall Z-1432-06 ยท LNO
ConvaTec
Active Life Non-Convex Drainable Stomahesive pouch-1 1/4' (32 mm) Product No: 022766 Manf. by ConvaTec, Skillman, NJ.
| Date | Aug 24, 2006 (initiated Jul 13, 2006) |
| Status | Terminated |
| Reason | Cartons labeled 1-1/4 inch size may contain units that are 1-1/2 inch size. |
| Root cause | Other |
| Action | Notification to all direct customes (tier 1) with letter to tier 1 distributors for tier 2 customers was sent via first class mail on 7/13/06 or direct visit by ConvaTec Sales Reps. |
| Quantity | 3,857 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K833625 | ACTIVE LIFE Convatec, A Division of E.R. Squibb & Sons, Nov 28, 1983 |