MEDLINE INDUSTRIES, LP - Northfield: namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,L

Hazard

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

Details from the source

Reason for recall: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. Distribution: Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia Quantity: 1669 units Lot/code info: 1) REF60010468, UDI/DI 10193489040319 (each) 20193489040316 (case), Lot Number 0000140099; 2) REF60010511, UDI/DI 10193489040357 (each) 20193489040354 (case), Lot Number 0000141267; 3) REF60020323, UDI/DI 10193489041071 (each) 20193489041078 (case), Lot Number 0000139976; 4) REF60020676, UDI/DI 10193489041200 (each) 20193489041207 (case), Lot Number 0000140410; 5) REF60035977, UDI/DI 10193489042672 (each) 20193489042679 (case), Lot Number 0000140081; 6) REF60040273, UDI/DI 10193489042832 (each) 20193489042839 (case), Lot Number 0000140896; 7) REF60100313, UDI/DI 10193489045048 (each) 20193489045045 (case), Lot Number 0000140520; 8) REF60131208, UDI/DI 10193489046762 (each) 20193489046769 (case), Lot Number 0000140075; 9) REF60131208, UDI/DI 10193489046762 (each) 20193489046769 (case), Lot Number 0000140364; 10) REF60140101, UDI/DI 10193489047868 (each) 20193489047865 (case), Lot Number 0000139979; 11) REF60140101, UDI/DI 10193489047868 (each) 20193489047865 (case), Lot Number 0000140016; 12) REF60190947, UDI/DI 10193489050677 (each) 20193489050674 (case), Lot Number 0000140835; 13) REF60231052, UDI/DI 10193489053203 (each) 20193489053200 (case), Lot Number 0000140045; 14) REF65190182, UDI/DI 10193489063028 (each) 20193489063025 (case), Lot Number 0000140258; 15) REF65190474, UDI/DI 10193489063059 (each) 20193489063056 (case), Lot Number 0000141271; 16) REF600800516, UDI/DI 10193489070347 (each) 20193489070344 (case), Lot Number 0000140829; 17) REF601309013, UDI/DI 10193489071

UPC codes

10193489040319, 20193489040316, 10193489040357, 20193489040354, 10193489041071, 20193489041078, 10193489041200, 20193489041207, 10193489042672, 20193489042679, 10193489042832, 20193489042839, 10193489045048, 20193489045045, 10193489046762, 20193489046769, 10193489047868, 20193489047865, 10193489050677, 20193489050674, 10193489053203, 20193489053200, 10193489063028, 20193489063025, 10193489063059, 20193489063056, 10193489070347, 20193489070344, 10193489071054, 20193489071051, 10193489072099, 20193489072096, 10193489072105, 20193489072102, 10193489073898, 20193489073895, 10193489074482, 20193489074489, 10193489095951, 20193489095958

Source

Official record: FDA (Device enforcement) ↗

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