Atlas FDA

Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open Tip, One Eye , Non sterile, 12

FDA device recall Z-0465-2011 · posted 2010-11-26 · Terminated

Recall details

Recalling firm
C.R. Bard, Inc., Urological Division
Reason for recall
The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French.
Action taken
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.
Root cause
Employee error
Status
Terminated
Product code
KNT
Quantity affected
108 eaches
Distribution
Nationwide Distribution: In the state of Ohio.
Date initiated
2010-10-28
Date posted
2010-11-26
Date terminated
2011-03-31
Location
Covington, GA

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