Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml LOT***Sterile EO*** Single use only, Manufactured and Distributed by***Rusch Inc., 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 10****
FDA Recall Z-0648-05 · Posted 2005-03-23
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Recalling FirmTeleflex Medical, Inc.
Recall StatusTerminated
Product CodeKNX
Date Initiated2004-05-13
Date Terminated2009-08-31
Product Quantity1227 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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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