CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report
namic convenience kits labeled as: Mts,4 Valve,Lft,Hrt,Kit-ahs-a*,NW recalled
Medline Industries LP - Northfield is recalling namic convenience kits labeled as: Mts,4 Valve,Lft,Hrt,Kit-ahs-a*,NW, distributed nationwide in the US. The recall was initiated on 12 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1431-2025
- FDA event ID
- 96367
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Feb 2025
- FDA classified
- 21 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Feb 2025 | Recall initiated by company | |
| 21 Mar 2025 | Classified by FDA | +37 days |
| 2 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
Questions about this recall
Why was it recalled?
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Which lots are affected?
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 10193489071054 (each) 20193489071051 (case), Lot Number 0000139959; 18) REF601905413, UDI/DI 10193489072099 (each) 20193489072096 (case), Lot Number 0000139674; 19) REF601905414, UDI/DI 10193489072105 (each) 20193489072102 (case), Lot Number 0000139097; 20) REF606604328, UDI/DI 10193489073898 (each) 20193489073895 (case), Lot Number 0000140043; 21) REF613000122, UDI/DI 10193489074482 (each) 20193489074489 (case), Lot Number 0000140963; 22) REF6010034281, UDI/DI 10193489095951 (each) 20193489095958 (case), Lot Number 0000139656; 23) REF6010034281, UDI/DI 10193489095951 (each) 20193489095958 (case), Lot Number 0000140079; 24) REF6010171931, UDI/DI 10193489104943 (each) 20193489104940 (case), Lot Number 0000140976; 25) REF6061073001, UDI/DI 10193489095692 (each) 20193489095699 (case), Lot Number 0000140936; 26) REF601316711A, UDI/DI 10197344028696 (each) 20197344028693 (case), Lot Number 0000139675; 27) REF60190776A, UDI/DI 10193489148763 (each) 20193489148760 (case), Lot Number 0000140484; 28) REF60191118A, UDI/DI 10193489180657 (each) 20193489180654 (case), Lot Number 0000139969.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 96367| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | namic convenience kits labeled as: Pml,72,Adult,Fll-mll,-,Oem recalled | Medline Industries LP - Northfield | Other | Nationwide | |
| CLASS II | namic convenience kits labeled as recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Other | Nationwide | |
| CLASS II | namic convenience kits labeled as: KIT,Arterial,60,PG recalled | Medline Industries LP - Northfield | Other | Nationwide |
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