FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit

FDA device recall Z-1441-2014 · posted 2014-04-09 · Terminated

Recall details

Recalling firm

Remington Medical Inc.

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 (-).

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.

Root cause

Labeling Change Control

Status

Terminated

Product code

DSA

Quantity affected

41,499 cables

Distribution

USA (nationwide) Distribution including Canada

Date initiated

2014-03-05

Date posted

2014-04-09

Date terminated

2018-04-09

Location

Alpharetta, GA

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