FDA Recall
Terminated
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
Recall: Z-0465-2011
·
Initiated October 28, 2010
Recall
- Recall Number
- Z-0465-2011
- Event Number
- 57117
- Firm
- C.R. Bard, Inc., Urological Division
- FEI Number
- 1018233
- Product Code
- KNT
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- October 28, 2010
- Posted
- November 26, 2010
- Terminated
- March 31, 2011
- Address
- 8195 Industrial Blvd Ne, Covington, GA, 30014-1497
Description
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
Reason
The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French.
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.
Distribution
Nationwide Distribution: In the state of Ohio.
Quantity
108 eaches