FDA Recall Terminated

ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15) 1 3/4 in. 45 mm

Recall: Z-1531-06 · Initiated July 31, 2006

Recall

Recall Number
Z-1531-06
Event Number
36268
Firm
ConvaTec
FEI Number
3011987967
Product Code
LNO
Status
Terminated
Root Cause
Other
Initiated
July 31, 2006
Posted
September 27, 2006
Terminated
May 10, 2007
Address
200 Headquarters Park Dr, Skillman, NJ, 08558-2624

Description

ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15) 1 3/4 in. 45 mm

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.

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