Recall Z-1441-2014
Remington Medical Inc. · initiated March 5, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.
Reason for recall
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 (-).
FDA-determined cause: Labeling Change Control
Action taken
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 with the existing FL-601-97 labeling (Instructions for Use) provided with the product. If you have distributed these products further, please forward copies of this notice and the revised Instructions for Use to any recipients as appropriate. If you have any questions regarding this communication, please contact RMIs sales representatives or customer service team at 800-989-0057, Monday - Friday, between the hours of 8 am - 4pm EST. Patient safety is the highest priority for Remington Medical, Inc. We appreciate your assistance with this matter and regret any inconvenience this may cause.
Details
- Recall number
- Z-1441-2014
- Initiated
- March 5, 2014
- Posted by FDA
- April 9, 2014
- Terminated
- April 9, 2018
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Quantity
- 41,499 cables
- Distribution
- USA (nationwide) Distribution including Canada
- Recalling firm
- Remington Medical Inc., Alpharetta, GA