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Terminated

Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558

FDA Recall Z-1179-2008 · Posted 2008-05-07

Recalling FirmConvaTec
Recall StatusTerminated
Product CodeEXB
Date Initiated2008-02-14
Date Terminated2008-10-21
Product Quantity3986 market units

Reason for Recall

Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.

Firm Action

Consignees were notified by an Urgent Product Recall Letter on 2/14/08. Updated letters were issued on 2/21/08 and 4/10/08 with expanded lot numbers. The letters instruct users to return any affected products and a product recall response form. For additional information, contact (908) 904-2199.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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