Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000m
FDA device recall Z-0058-2008 · posted 2007-10-23 · Terminated
Recall details
- Recalling firm
- Remington Medical Inc.
- Reason for recall
- Sterility, inadequate -- Pathway may not be sterile as labeled.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- EXF
- Quantity affected
- 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.
- Date initiated
- 2007-07-23
- Date posted
- 2007-10-23
- Date terminated
- 2009-04-06
- Location
- Alpharetta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRAINAGE BAG (K990428) | Remington Medical, Inc. | 1999-08-12 |