Recall Z-2223-2010 ยท DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Remington Medical Inc.
Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005 Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs).
| Date | Aug 13, 2010 (initiated May 19, 2010) |
| Status | Terminated |
| Reason | The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971968 | SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) Remington Medical, Inc., Jul 23, 1997 |