FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc., Urological Division: 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 number
- Z-0465-2011
- Recalling firm
- C.R. Bard, Inc., Urological Division
- 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
- Status
- Terminated
- Initiated
- 2010-10-28
- Posted
- 2010-11-26
- Terminated
- 2011-03-31
- Reason
- The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French.
- 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
- 108 eaches
- Distribution
- Nationwide Distribution: In the state of Ohio.
- Lot, serial or model codes
- Catalog Number: 8006370, Lot number GFUC3605
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28