Remington Medical, Inc.
6245 Shiloh Road, Alpharetta, GA, US
Registered product codes
38 product codes
Recent MDR events
50 on file
- DISPOSABLE SURGICAL PACING CABLE WITH CONNECTOR PINS FOR MEDTRONIC TEMPORARY PACJul 22, 2026Malfunction25904259
- 6 FOOT DISPOSABLE EXTENSION CABLES WITH SAFE CONNECT/SCREW-DOWNMar 13, 2026Malfunction1056553-2026-00001
- 6 FOOT DISPOSABLE EXTENSION CABLES WITH SAFE CONNECT/SCREW-DOWNMar 2, 2026Malfunction24477497
- DRAINAGE BAGDec 24, 2025Malfunction23887814
- 6 FOOT DISPOSABLE EXTENSION CABLE WITH SAFE CONNECT / SCREW-DOWNAug 22, 2023Malfunction17595087
- FL-601-97 DISPOSABLE EXTENSION CABLEApr 4, 2023Malfunction1056553-2023-00001
- EPICARDIAL PACING- DISPOSABLE SCREW DOWN EXTENSION CABLESMar 8, 2023MalfunctionMW5115599
- SWAN GANZAug 5, 2019InjuryMW5088790
- BIOTRACE TEMPO PACING LEADSep 25, 2018InjuryMW5080100
- ANALYER CABLE 12 FT DISPOSABLEJul 23, 2018MalfunctionMW5078531
Recalls
20 on file
- Open, ClassifiedDec 5, 2023
There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
View FDA record ↗ - TerminatedDec 28, 2022
The stylet is longer than specified on the label
View FDA record ↗ - TerminatedApr 9, 2014
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 (-).
View FDA record ↗ - TerminatedOct 9, 2012
Sterility of the product may be compromised.
View FDA record ↗ - TerminatedJun 2, 2011
There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.
View FDA record ↗ - TerminatedMar 7, 2011
There is a potential for the needle hubs to break during use.
View FDA record ↗ - TerminatedMar 7, 2011
There is a potential for the needle hubs to break during use.
View FDA record ↗ - TerminatedMar 7, 2011
There is a potential for the needle hubs to break during use.
View FDA record ↗ - TerminatedMar 7, 2011
There is a potential for the needle hubs to break during use.
View FDA record ↗ - TerminatedMar 7, 2011
There is a potential for the needle hubs to break during use.
View FDA record ↗
Compliance history
Matched by FEI 3007014520.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.