FDA Medical Device Recalls (openFDA)
ConvaTec: ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60) 1 3/4 in. 45 mm
- Recall number
- Z-1532-06
- Recalling firm
- ConvaTec
- Product
- ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60) 1 3/4 in. 45 mm
- Status
- Terminated
- Initiated
- 2006-07-31
- Posted
- 2006-09-27
- Terminated
- 2007-05-10
- 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.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- REF 413145; UPC 0034 13145 Lot #6E3589N
- 510(k) numbers
- ["K840568"]
- PMA numbers
- not on file
- Product code
- LNO
- Firm FEI
- 3011987967
- Firm city
- Skillman
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28