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Recall Observatory FDA recall evidence

Device product

Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.

Z-2388-2015

July 07, 2015

Class II

Product summary

Firm
C.R. Bard, Inc.
Event
Event 71722
Status
Terminated
Classification
Class II
Quantity
534,972 each
Official record key
device-enforcement:Z-2388-2015

Official wording

Reason: Potential breach of the sterile barrier packaging.

Code information: Lot Number 53620387, 53621274, 53621279

Distribution pattern: Nationwide Distribution-including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI AND DC.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of the sterile barrier