ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15) 1 3/4 in. 45 mm
FDA device recall Z-1531-06 · posted 2006-09-27 · Terminated
Recall details
- Recalling firm
- ConvaTec
- Reason for recall
- Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNO
- Distribution
- Nationwide
- Date initiated
- 2006-07-31
- Date posted
- 2006-09-27
- Date terminated
- 2007-05-10
- Location
- Skillman, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACTIVE LIFE ONE-PIECE CLOSED-END POUCH (K840568) | Convatec, A Division of E.R. Squibb & Sons | 1984-05-02 |