namic convenience kits labeled as: 1) MTS recall
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)…
Why was namic convenience kits labeled as: 1) MTS recalled?
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- 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)…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1669 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
- Recall date
- April 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)