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Terminated

Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent catheter.

FDA Recall Z-2387-2015 · Posted 2015-08-14

Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeKOD
Date Initiated2015-07-07
Date Terminated2017-07-21
Product Quantity16,799 each

Reason for Recall

Potential breach of the sterile barrier packaging.

Firm Action

A recall notice was sent to consignees on 7/7/2015 asking them to discontinue use of the product. The letter to the distributors requested a sub-recall. Both letters included a response form to be returned to Bard.

Root Cause

Unknown/Undetermined by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000723HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)Rochester Medical Corp. · 2000-05-19

Official Source

View FDA Recall →

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

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