RegWardenFDA facility compliance records
Recall

Class II — C.R. Bard, Inc.

Recalling firmC. R. Bard, Inc.
Registered facilityView this company's 19 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonPotential breach of the sterile barrier packaging.
ProductMagic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
Quantity534,972 each
DistributionNationwide 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.
Initiated2015-07-07
Classified2015-08-14
Terminated2017-07-21
Recall numberZ-2388-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — C.R. Bard, Inc. (Z-2388-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71722/

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