FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
- Recall number
- Z-0967-2017
- Recalling firm
- C.R. Bard, Inc.
- Product
- SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
- Status
- Terminated
- Initiated
- 2016-07-11
- Posted
- not on file
- Terminated
- 2021-10-05
- Reason
- The product contained a latex catheter instead of a silicone catheter.
- Root cause
- Labeling mix-ups
- Action
- Bard Medical sent an Urgent : Medical Device Product Recall Letter dated July 11, 2016, to all affected customers. The letter requested that they check inventory and quarantine product, and if the product had been further distributed, they need to conduct a sub-recall. The letter included a reply form to be returned. For further questions, please call (770) 784-6220.
- Quantity
- 2690 units
- Distribution
- US Distribution to the states of : CA, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, NE, NV, NJ, NM, NY, OR, SC, TN, TX, UT, VA, WA
- Lot, serial or model codes
- NGAQ4149
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KNX
- 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