Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml Lot***Sterile EO***Manufactured and Distr
FDA device recall Z-0647-05 · posted 2005-03-23 · Terminated
Recall details
- Recalling firm
- Teleflex Medical, Inc.
- Reason for recall
- Firm received complaints of leaking urine collection bags.
- Action taken
- Consignees were notified by letter on 5/13/2004. A follow up letter was sent on 11/22/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNX
- Quantity affected
- 6029 bags
- Distribution
- Nationwide, Australia, Japan and the UK
- Date initiated
- 2004-05-13
- Date posted
- 2005-03-23
- Date terminated
- 2009-08-31
- Location
- Duluth, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SECOND NATURE(TM) (K871387) | Advanced Clinical Products, Inc. | 1987-05-29 |