| Class 2 Device Recall FASLOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. |  |
Date Initiated by Firm | March 05, 2014 |
Date Posted | April 09, 2014 |
Recall Status1 |
Terminated 3 on April 09, 2018 |
Recall Number | Z-1441-2014 |
Recall Event ID |
67752 |
510(K)Number | K971968 |
Product Classification |
Cable, transducer and electrode, patient, (including connector) - Product Code DSA
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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. |
Code Information |
Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171. |
Recalling Firm/ Manufacturer |
Remington Medical Inc. 6830 Meadowridge Ct Alpharetta GA 30005-2202
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For Additional Information Contact | Christopher M. Brown 770-888-8520 |
Manufacturer 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 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DSA
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