Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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

FDA Recall Z-0465-2011 · Posted 2010-11-26

Recalling FirmC.R. Bard, Inc., Urological Division
Recall StatusTerminated
Product CodeKNT
Date Initiated2010-10-28
Date Terminated2011-03-31
Product Quantity108 eaches

Reason for Recall

The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution: In the state of Ohio.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑