Recall Z-2386-2015
C.R. Bard, Inc. · initiated July 7, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
Codes / lots: Lot Number 73600003, 73600006, 7360007, 73600011, 73600012, 73600013, 73600016, 73600017, 73600020, 73600021, 73600024, 73600080, 73600081, 73600082, 73600095, 73600096, 73600097, 73600123, 73600124, 73600125, 73600126, 73600144, 73600145, 73600163, 73600164, 73600167, 73600181, 73600196, 73600217, 73600218
Reason for recall
Potential breach of the sterile barrier packaging.
FDA-determined cause: Unknown/Undetermined by firm
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.
Details
- Recall number
- Z-2386-2015
- Initiated
- July 7, 2015
- Posted by FDA
- August 14, 2015
- Terminated
- July 21, 2017
- Product code
- KOD – Catheter, Urological
- Quantity
- 37,686 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 AND DC.
- Recalling firm
- C.R. Bard, Inc., Covington, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2384-2015 Class II | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box)…Potential breach of the sterile barrier packaging. | 07/07/2015Terminated |
| Z-2385-2015 Class II | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box)…Potential breach of the sterile barrier packaging. | 07/07/2015Terminated |
| Z-2387-2015 Class II | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box)…Potential breach of the sterile barrier packaging. | 07/07/2015Terminated |
| Z-2388-2015 Class II | Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion…Potential breach of the sterile barrier packaging. | 07/07/2015Terminated |