FDA Medical Device Recalls (openFDA)
Teleflex Medical, Inc.: 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
- Recall number
- Z-0647-05
- Recalling firm
- Teleflex Medical, Inc.
- 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
- Status
- Terminated
- Initiated
- 2004-05-13
- Posted
- 2005-03-23
- Terminated
- 2009-08-31
- Reason
- Firm received complaints of leaking urine collection bags.
- Root cause
- Other
- Action
- Consignees were notified by letter on 5/13/2004. A follow up letter was sent on 11/22/2004.
- Quantity
- 6029 bags
- Distribution
- Nationwide, Australia, Japan and the UK
- Lot, serial or model codes
- Lots 121870, 121871, 121872, 122515, 122517, 122518, 123273, 123274, 123275, 124066, 124333 and 124334.
- 510(k) numbers
- ["K871387"]
- PMA numbers
- not on file
- Product code
- KNX
- Firm FEI
- 2429473
- Firm city
- Duluth
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28