Disposable Surgical Cable…

Date posted by the FDA

Aug. 13, 2010

Status

Terminated

Filed by

Remington Medical Inc.

Product

Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005 Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs).

Reason

The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.

Distribution pattern

AZ, CA, CO, CT, DE, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NM, NY, OH, OK, OR, PA, SC, TX, TN, TX, VA, WA, WI and Canada.

Quantity

1488 units

Codes and lots

Lot number: 100701

Recall started

May 19, 2010

Device type

Cable, Transducer And Electrode, Patient, (Including Connector)

Root cause (FDA)

Process design

What the company told customers

Consignees were notified on/about 05/19/2010. They were instructed to examine their inventory and quarantine product subject to the recall. If they distributed the product, they were advised to identify their customers and notify them of the recall (via the recall letter). A Return Authorization was provided. More information can be obtained by calling 770.888.8520.

Recall number

Z-2223-2010

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2223-2010. The agency record governs; check it and the company before acting.