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