Z-0465-2011

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

Name: Z-0465-2011 Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open Tip, One Eye , Non...
Creator: C.R. Bard, Inc., Urological Division
Published: 2010-10-28
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2010-10-28 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc., Urological Division began a recall of 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... on 2010-10-28. The reason FDA records is "The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0465-2011
Status: Terminated
Initiated: 2010-10-28
Posted: 2010-11-26
Terminated: 2011-03-31
Recalling firm: C.R. Bard Inc
Product: 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
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French.
Root cause tag: manufacturing process
FDA 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 in commerce: 108 eaches
Distribution: Nationwide Distribution: In the state of Ohio.
Product codes and lots: Catalog Number: 8006370, Lot number GFUC3605

Product code KNT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)