Recall Z-0465-2011 ยท KNT Tubes, Gastrointestinal (And Accessories)
C.R. Bard, Inc., Urological Division
Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open Tip, One Eye , Non sterile, 12 Each, C.R. Bard, Inc., Covington, GA 30014
| Date | Nov 26, 2010 (initiated Oct 28, 2010) |
| Status | Terminated |
| Reason | The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French. |
| Root cause | Employee error |
| Action | Bard sent an Urgent Product Recall Notification letter dated October 28, 2010 to the consignee. They were instructed to return any outstanding inventory of the affected product. They were advised to notify their consignees of the recall and to retrieve relevant product from those locations. Affected products received by Bard Medical will be destroyed. BMD can be contacted at 1 770 784-6969 for questions or assistance. |
| Quantity | 108 eaches |
| Distribution | Nationwide Distribution: In the state of Ohio. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.