Z-1532-06

ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60) 1 3/4...

Name: Z-1532-06 ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60) 1 3/4...
Creator: ConvaTec
Published: 2006-07-31
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2006-07-31 / Terminated / root cause: labeling and UDI

FDA source

ConvaTec began a recall of ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60) 1 3/4 in. 45 mm on 2006-07-31. The reason FDA records is "Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1532-06
Status: Terminated
Initiated: 2006-07-31
Posted: 2006-09-27
Terminated: 2007-05-10
Recalling firm: ConvaTec Limited
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
Product code: LNO
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.
Root cause tag: labeling and UDI
FDA 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
Product codes and lots: REF 413145; UPC 0034 13145 Lot #6E3589N

Product code LNO

K840568Class IActive Life One-Piece Closed-End PouchConvatec, A Division of E.R. Squibb & Sons / cleared 1984-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)