Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge
FDA device recall Z-2223-2010 · posted 2010-08-13 · Terminated
Recall details
- Recalling firm
- Remington Medical Inc.
- Reason for recall
- The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
- Action taken
- Consignees were notified on/about 05/19/2010. They were instructed to examine their inventory and quarantine product subject to the recall. If they distributed the product, they were advised to identify their customers and notify them of the recall (via the recall letter). A Return Authorization was provided. More information can be obtained by calling 770.888.8520.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DSA
- Quantity affected
- 1488 units
- Distribution
- AZ, CA, CO, CT, DE, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NM, NY, OH, OK, OR, PA, SC, TX, TN, TX, VA, WA, WI and Canada.
- Date initiated
- 2010-05-19
- Date posted
- 2010-08-13
- Date terminated
- 2010-11-29
- 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 |
|---|---|---|
| SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) (K971968) | Remington Medical, Inc. | 1997-07-23 |