Recall Z-1441-2014 ยท DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Remington Medical Inc.
FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.
| Date | Apr 9, 2014 (initiated Mar 5, 2014) |
| Status | Terminated |
| Reason | Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-). |
| Root cause | Labeling Change Control |
| Action | Remington Medical Inc sent an Field Safety Notice dated March 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please be aware that the typographical error described above is included in the FL-601-97 Instructions for Use (RM-0154 Rev 05) provided with the lots that you have received as identified below. RMI has corrected the typographical error in the revised FL-601-97 Instructions for Use (RM-0154 Rev 5.1) which is attached to this communication. Please incorporate the information contained in the attachment |
| Quantity | 41,499 cables |
| Distribution | USA (nationwide) Distribution including 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 |