Z-0647-05

Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, 1000 ml LotSterile...

Name: Z-0647-05 Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml Lot***Sterile...
Creator: Teleflex Medical, Inc.
Published: 2004-05-13
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2004-05-13 / Terminated

FDA source

Teleflex Medical, Inc. began a recall of 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... on 2004-05-13. The reason FDA records is "Firm received complaints of leaking urine collection bags". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0647-05
Status: Terminated
Initiated: 2004-05-13
Posted: 2005-03-23
Terminated: 2009-08-31
Recalling firm: Teleflex Medical
Product: 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
Product code: KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Reason for recall: Firm received complaints of leaking urine collection bags.
FDA root cause: Other
Action: Consignees were notified by letter on 5/13/2004. A follow up letter was sent on 11/22/2004.
Quantity in commerce: 6029 bags
Distribution: Nationwide, Australia, Japan and the UK
Product codes and lots: Lots 121870, 121871, 121872, 122515, 122517, 122518, 123273, 123274, 123275, 124066, 124333 and 124334.

Product code KNX

K871387Class IISecond Nature(tm)Advanced Clinical Products, Inc. / cleared 1987-05-29

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)