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Terminated

Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml Lot***Sterile EO***Manufactured and Distributed by***Rusch Inc. 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 1

FDA Recall Z-0647-05 · Posted 2005-03-23

Recalling FirmTeleflex Medical, Inc.
Recall StatusTerminated
Product CodeKNX
Date Initiated2004-05-13
Date Terminated2009-08-31
Product Quantity6029 bags

Reason for Recall

Firm received complaints of leaking urine collection bags.

Firm Action

Consignees were notified by letter on 5/13/2004. A follow up letter was sent on 11/22/2004.

Root Cause

Other

Distribution Pattern

Nationwide, Australia, Japan and the UK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K871387SECOND NATURE(TM)Advanced Clinical Products, Inc. · 1987-05-29

Official Source

View FDA Recall →

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

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