Recall Z-0058-2008 ยท EXF Bag, Bile Collecting
Remington Medical Inc.
Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Remington Medical, Inc., Alpharetta, GA 30005.
| Date | Oct 23, 2007 (initiated Jul 23, 2007) |
| Status | Terminated |
| Reason | Sterility, inadequate -- Pathway may not be sterile as labeled. |
| Root cause | Process control |
| Action | Consignees were notified by Urgent Recall Letter (dated 07/23/07) via fax from 07/24/2007 through 07/27/2007. They were instructed to quarantine all affected product in inventory. If product was distributed they were instructed to identify their customers and notify them of the recall via copy of the notification letter. |
| Quantity | 45,000 units |
| Distribution | Nationwide Distribution -- including states of AL, AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, KY, MD, MI, MT, NB, NC, OH, NY, PA, RI, TN, WA, WV, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990428 | DRAINAGE BAG Remington Medical, Inc., Aug 12, 1999 |