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Terminated

SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device

FDA Recall Z-0967-2017 · Posted None

Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeKNX
Date Initiated2016-07-11
Date Terminated2021-10-05
Product Quantity2690 units

Reason for Recall

The product contained a latex catheter instead of a silicone catheter.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

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

Official Source

View FDA Recall →

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

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