Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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.
Why it was recalled
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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.
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
Recall record
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product type
- Devices
- Recall number
- Z-1431-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Origin
- Northfield, IL
- Recall initiated
- 2025-02-12
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1431-2025 · Source: openFDA enforcement.