FDAFDA · Food and drugs·Recall number Z-1441-2014
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.
Published April 16, 2014 · Recall initiated: March 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 (-).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remington Medical Inc.
- Distributor
- USA (nationwide) Distribution including Canada
- Lot
- Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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