Recall Z-0800-2019 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
Bard Medical Division
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
| Date | Dec 6, 2018 |
| Status | Open, Classified |
| Reason | Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port. |
| Root cause | Device Design |
| Action | Bard Medical Division notified customers on about 12/06/2018 via "MEDICAL DEVICE PRODUCT NOTIFICATION" letter. Customers were instructed to examine their inventory and identify any product subject to the recall, product return is not required, and if product was further distributed or transferred to notify those customers and include a copy of the medical device communication letter provided. Questions can be directed to Customer Service at 1-800-526-4455 or BMD.FieldAction@crbard.com. |
| Quantity | 450 units |
| Distribution | US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER C.R. Bard, Inc., Aug 18, 1994 |