namic convenience kits labeled as: 1) MTS — Class II medical device recall Z-1431-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-02, distributed nationwide. The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near t
| Recall number | Z-1431-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-02-12 |
| Classified | 2025-03-21 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL, NZ, SK |
| Quantity | 1,669 units |
| UPC / GTIN / UDI-DI | 10193489040319, 10193489040357, 10193489041071, 10193489041200, 10193489042672, 10193489042832, 10193489045048, 10193489046762, 10193489047868, 10193489050677, 10193489053203, 10193489063028, 10193489063059, 10193489070347, 10193489071054, 10193489072099, 10193489072105, 10193489073898, 10193489074482, 10193489095692, 10193489095951, 10193489104943, 10193489148763, 10193489180657, 10197344028696 and 25 more |
| Lot numbers | 0000139097, 0000139656, 0000139674, 0000139675, 0000139959, 0000139969, 0000139976, 0000139979, 0000140016, 0000140043, 0000140045, 0000140075, 0000140079, 0000140081, 0000140099, 0000140258, 0000140364, 0000140410, 0000140484, 0000140520, 0000140829, 0000140835, 0000140896, 0000140936, 0000140963, 0000140976, 0000141267, 0000141271 |
| Model numbers | 60010468, 60010511, 60020323, 60020676, 60035977, 60040273, 600800516, 60100313, 6010034281, 6010171931, 601309013, 60131208, 601316711A, 60140101, 601905413, 601905414, 60190776A, 60190947, 60191118A, 60231052, 6061073001, 606604328, 613000122, 65190182, 65190474 |
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.
Reason for recall
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1431-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.