Recall Z-1531-06 ยท LNO
ConvaTec
ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15) 1 3/4 in. 45 mm
| Date | Sep 27, 2006 (initiated Jul 31, 2006) |
| Status | Terminated |
| Reason | Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label. |
| Root cause | Other |
| Action | A recall notification was mailed by first class mail on 7/31/2006 to all direct customers with letter to tier 1 distributors for tier 2 end users. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K840568 | ACTIVE LIFE ONE-PIECE CLOSED-END POUCH Convatec, A Division of E.R. Squibb & Sons, May 2, 1984 |