Recall Z-1431-2025

MEDLINE INDUSTRIES, LP - Northfield · initiated February 12, 2025

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,MEM HLTHCARE, REF 60035977; 6) MTS,LEFT HEART,KIT,J*,M*,C*, REF 60040273; 7) MTS,LEFT HEART,KIT,C*,C*, REF 60100313; 8) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 9) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 10) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 11) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 12) MTS,LEFT HEART,MAN,KIT,S*-BALTIMORE, REF 60190947; 13) MTS-LEFT HEART,KIT-W*,H* HOSP PG, REF 60231052; 14) MTO,3-VALVE,KIT-T*,A*-PG, REF 65190182; 15) MTO,LEFT HEART,KIT,-,S* F*,-,PG, REF 65190474; 16) MTS,DR.,MCKAYS,4V,KIT,-,H* HOSP PG, REF 600800516; 17) MTS,EP,KIT,-,S*,TEACHING HOSPITAL PG, REF 601309013; 18) MTS,RHT,HRT-S* HOSP &,MC, REF 601905413; 19) MTS,PEDS,LFT,&,RT,HRT-S* HOSP, REF 601905414; 20) MTO,SCH,BEL,J*,H*-ST-PAUL,-,PG, REF 606604328; 21) LHK,-,MID,3VCOMP,OFF,PS,S10RA, REF 613000122; 22) MTS,LHK,W* HOSPITAL, REF 6010034281; 23) MTS,LHK,W* HOSPITAL, REF 6010034281; 24) MTS,LHK,P*,P* MED CTR, REF 6010171931; 25) MTS,LHK,M* HEALTHCARE,MGMT, REF 6061073001; 26) TVR US B* INTEGRATED SERVICE CENT, REF 601316711A; 27) LHK-S* MEDICAL CENTER,A*, REF 60190776A; 28) LHK,-,S*,AND,W* HOSPITAL, REF 60191118A.

Codes / lots: 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)…

Reason for recall

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

FDA-determined cause: Process change control

Action taken

Medline Industries issued two notices, delivered using email and US Mail: 1) a MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines and 2) a MEDICAL DEVICE RECALL notice for the kits containing the affected product; both notices explained the issue and the hazard. The MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines requested that the consignee destroy any affected inventory and reply to receive credit. The MEDICAL DEVICE RECALL notice for the kits containing the affected product requested the consignee respond to the notice and upon response, Medline will provide labeling that states the following: "ATTENTION This kit contains a recalled item Medline Pressure Monitoring Lines VPN: 24614303 DO NOT USE THIS COMPONENT The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*" Consignees were directed to notify their customers of these actions.

Details

Recall number
Z-1431-2025
Initiated
February 12, 2025
Posted by FDA
March 21, 2025
Product code
OEZ – Cardiovascular Procedure Kit
Quantity
1669 units
Distribution
Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1428-2025 Class IInamic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical…The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near… 02/12/2025Open, Classified
Z-1429-2025 Class IInamic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit…The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near… 02/12/2025Open, Classified
Z-1430-2025 Class IInamic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical…The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near… 02/12/2025Open, Classified