Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. I
FDA device recall Z-2388-2015 · posted 2015-08-14 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc.
- Reason for recall
- Potential breach of the sterile barrier packaging.
- Action taken
- 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
- Status
- Terminated
- Product code
- KOD
- Quantity affected
- 534,972 each
- Distribution
- 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
- Date initiated
- 2015-07-07
- Date posted
- 2015-08-14
- Date terminated
- 2017-07-21
- Location
- Covington, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) (K000723) | Rochester Medical Corp. | 2000-05-19 |