Z-1441-2014Class II

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

Name: Z-1441-2014 FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended...
Creator: Remington Medical Inc.
Published: 2014-03-05
License: https://open.fda.gov/license/

Remington Medical / initiated 2014-03-05 / Terminated / root cause: labeling and UDI

FDA source

Remington Medical Inc. began a recall of FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation... on 2014-03-05. FDA classified it as Class II and gives the reason as "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 (-)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1441-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Posted: 2014-04-09
Terminated: 2018-04-09
Recalling firm: Remington Medical
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.
Product code: DSA Cable, Transducer And Electrode, Patient, (Including Connector)
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 (-).
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 41,499 cables
Distribution: USA (nationwide) Distribution including Canada
Product codes and lots: Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1441-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1441-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-09

Product code DSA

K971968Class IISafe Connect Surgical Cable (S-101-97/S-201-97/Fl-601-97)Remington Medical, Inc. / cleared 1997-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)