MEDLINE INDUSTRIES, LP - Northfield: Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 40

Hazard

Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.

Details from the source

Reason for recall: Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. Distribution: US Nationwide. Quantity: 398 units Lot/code info: 1) 401211RH, UDI-DI: 10197344043736(each), 10197344043736(case), Lot Number: EP250106; 2) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP241118; 3) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP250106; 4) 401223RH, UDI-DI: 10197344043705(each), 10197344043705(case), Lot Number: EP250106; 5) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP241118; 6) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP250106; 7) 401227RH, UDI-DI: 10197344043682(each), 10197344043682(case), Lot Number: EP250106; 8) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP241118; 9) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP250106; 10) 401261RH, UDI-DI: 10197344043651(each), 10197344043651(case), Lot Number: EP250106; 11) 401305RH, UDI-DI: 10197344043637(each), 10197344043637(case), Lot Number: EP250106; 12) 401309RH, UDI-DI: 10197344043613(each), 10197344043613(case), Lot Number: EP250106; 13) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP241118; 14) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP250106; 15) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP241118; 16) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP250106; 17) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP241118; 18) 401399RH,

UPC codes

10197344043736, 10197344043712, 10197344043705, 10197344043699, 10197344043682, 10197344043668, 10197344043651, 10197344043637, 10197344043613, 10197344043569, 10197344043545, 10197344043521, 10197344043491, 10197344043484, 10197344043477, 10197344043460, 10197344043453, 10197344043439, 10197344044245, 10197344044252, 10197344044269, 10197344044283, 10197344044290, 10197344044306, 10197344044313, 10197344044320, 10197344044351, 10197344044382, 10197344044399, 10197344044405, 10197344044436, 10197344044443, 10197344044450, 10197344044467, 10197344044498, 10197344044566, 10197344044573, 10197344044597, 10197344043835

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.