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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96367

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 12, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

Z-1428-2025
Recall number
Z-1428-2025
Initiated
February 12, 2025
Classification
Class II
Status
Ongoing
Quantity
4400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UDI/DI 10193489067507 (each), 20193489067504 (case), Lot number 0000140528

Distribution pattern

Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia

device · product 2 of 4

namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160

Z-1429-2025
Recall number
Z-1429-2025
Initiated
February 12, 2025
Classification
Class II
Status
Ongoing
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UDI/DI 10193489064803 (each), 20193489064800 (case), Lot number 0000140054

Distribution pattern

Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia

device · product 3 of 4

namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710

Z-1430-2025
Recall number
Z-1430-2025
Initiated
February 12, 2025
Classification
Class II
Status
Ongoing
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

UDI/DI 10193489070279 (each),20193489070276 (case), Lot number 0000141266

Distribution pattern

Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia

device · product 4 of 4

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.

Z-1431-2025
Recall number
Z-1431-2025
Initiated
February 12, 2025
Classification
Class II
Status
Ongoing
Quantity
1669 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia