Recalls / —
—#138830
Product
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
- FDA product code
- KOD — Catheter, Urological
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K000723
- Affected lot / code info
- Lot Number 73600014, 73600079, 73600110, 73600128, 73600219
Why it was recalled
Potential breach of the sterile barrier packaging.
Root cause (FDA determination)
Unknown/Undetermined by firm
Action the firm took
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.
Recalling firm
- Firm
- C.R. Bard, Inc.
- Address
- 8195 Industrial Blvd NE, Covington, Georgia 30014-1497
Distribution
- 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.
Timeline
- Recall initiated
- 2015-07-07
- Posted by FDA
- 2015-08-14
- Terminated
- 2017-07-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #138830. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.