| | Class 3 Device Recall |  |
| Date Initiated by Firm | May 13, 2004 |
|---|
| Date Posted | March 23, 2005 |
|---|
| Recall Status1 |
Terminated 3 on August 31, 2009 |
| Recall Number | Z-0648-05 |
|---|
| Recall Event ID |
31009 |
| Product Classification |
Collector, Urine, (And Accessories) For Indwelling Catheter - Product Code KNX
|
| Product | 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**** |
|---|
| Code Information |
Lots 121848, 122514, 124332, 125309 and 125885 |
Recalling Firm/
Manufacturer |
Teleflex Medical, Inc.
2450 Meadowbrook Pkwy
Duluth GA 30096-4635
|
| For Additional Information Contact | Ms Diane Luo
919-361-4034 |
|---|
Manufacturer Reason
for Recall | Firm received complaints of leaking urine collection bags. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified by letter on 5/13/2004. A follow up letter was sent on 11/22/2004. |
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| Quantity in Commerce | 1227 bags |
|---|
| Distribution | Nationwide, Australia, Japan and the UK |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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