SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119
FDA device recall Z-0803-2019 · posted 2019-02-06 · Terminated
Recall details
- Recalling firm
- Bard Medical Division
- Reason for recall
- potential for urine leakage around the vent on the vented sample port
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MJC
- Quantity affected
- 883,171 units
- Distribution
- US, Canada, UAE
- Date initiated
- 2018-12-13
- Date posted
- 2019-02-06
- Date terminated
- 2020-11-02
- Location
- Covington, GA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER (K910318) | C.R. Bard, Inc. | 1994-08-18 |