Z-2223-2010

Disposable Surgical Cable

Name: Z-2223-2010 Disposable Surgical Cable
Creator: Remington Medical Inc.
Published: 2010-05-19
License: https://open.fda.gov/license/

Remington Medical / initiated 2010-05-19 / Terminated / root cause: manufacturing process

FDA source

Remington Medical Inc. began a recall of Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005 Usage... on 2010-05-19. The reason FDA records is "The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2223-2010
Status: Terminated
Initiated: 2010-05-19
Posted: 2010-08-13
Terminated: 2010-11-29
Recalling firm: Remington Medical
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).
Product code: DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Reason for recall: The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 1488 units
Distribution: 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.
Product codes and lots: Lot number: 100701

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)