Recall Z-2872-2017 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
C.R. Bard, Inc.
BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, colle
| Date | Jun 2, 2017 |
| Status | Terminated |
| Reason | Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier. |
| Root cause | Process control |
| Action | Bard Medical a Medical Device letter dated June 2, 2017 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. The notification requests that consignees examine inventory and identify any product on hand. The firm indicates that product return is not required, but customers are encouraged to call 1-800-526-4455 if product doesn't meet their needs or if they have any questions regarding the recall. If product was further distributed, the firm requests that the provided recall notification be forwarded to the respective organization. |
| Quantity | 2,350 units |
| Distribution | US Nationwide in the states of CA, CO, FL, IL, IN, LA, MN, MO, NC, NJ, NY, OH, OK, PA, TX, WY, including PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.