Recall Z-0803-2019 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
Bard Medical Division
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A33
| Date | Feb 6, 2019 (initiated Dec 13, 2018) |
| Status | Terminated |
| Reason | potential for urine leakage around the vent on the vented sample port |
| Root cause | Device Design |
| Action | Bard sent a Medical Device Notification letter dated December 13, 2018 to affected customers. The letter identified the affected product, problem nd actions to be taken. The distributors were instructed to forward the notice to their affected consignees. |
| Quantity | 883,171 units |
| Distribution | US, Canada, UAE |
| 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 |