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FDA-Device2026-04-15Class I

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SY

Medline Industries, LP
Hazard
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Sold states
Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).
Affected count
149439 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1717-2026

Original summary

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107 Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. Medline SKU 60010027, Lot Number 25EBF689; Medline SKU 60010027, Lot Number 25CBL960; Medline SKU 60010027, Lot Number 24LBO743; Medline SKU 60010195, Lot Number 25ABI082; Medline SKU 60010195, Lot Number 24IBJ827; Medline SKU 60010195, Lot Number 24HBO437; Medline SKU 60010195, Lot Number 24DBR149; Medline SKU 60010195, Lot Number 24CBF820; Medline SKU 60011433, Lot Number 26BBJ156; Medline SKU 60011433, Lot Number 26ABH642; Medline SKU 60011433, Lot Number 25KBJ356; Medline SKU 60011433, Lot Number 25HBQ865; Medline SKU 60011433, Lot Number 25FBS131; Medline SKU 60011433, Lot Number 25DBR246; Medline SKU 60011433, Lot Number 25CBS392; Medline SKU 60011433, Lot Number 25CBB739; Medline SKU 60011433, Lot Number 24JBR628; Medline SKU 60011433, Lot Number 24EBL302; Medline SKU 60011433, Lot Number 24BBS083; Medline SKU 60011433, Lot Number 23LBH316; Medline SKU 60011433, Lot Number 23JBP386; Medline SKU 60011433, Lot Number 23HBB765; Medline SKU 60011433, Lot Number 23FBC617; Medline SKU 60011433, Lot Number 23EBD152; Medline SKU 60011433, Lot Number 23DBR429; Medline SKU 60020323, Lot Number 25LBK008; Medline SKU 60020323, Lot Number 25JBJ120; Medline SKU 60020323, Lot Number 25HBQ807; Medline SKU 60020323, Lot Number 25GBA069; Medline SKU 60020323, Lot Number 25EBC643; Medline SKU 60020323, Lot Number 25CBE212; Medline SKU 60023904, Lot Number 26BBB137; Medline SKU 60023904, Lot Number 26ABL323; Medline SKU 60023904, Lot Number 25JBM214; Medline SKU 60023904, Lot Number 25EBM357; Medline SKU 60023904, Lot Number 25DBC905; Medline SKU 60023904, Lot Number 25CBU751; Medline SKU 60023904, Lot Number 25BBL199; Medline SKU 60023904, Lot Number 25ABP367; Medline SKU 60033123, Lot Number 25LBD357; Medline SKU 60033123, Lot Number 25JBS750; Medline SKU 60033123, Lot Number 25IBF219; Medline SKU 60033123, Lot Number 25HBQ032; Medline SKU 60033123, Lot Number 25GBJ123; Medline SKU 60033123, Lot Number 25FBF145; Medline SKU 60033123, Lot Number 25BBR862; Medline SKU 60033123, Lot Number 25BBI613; Medline SKU 60035431, Lot Number 25FBJ204; Medline SKU 60035431, Lot Number 25FBJ126; Medline SKU 60035431, Lot Number 25DBR499; Medline SKU 60035431, Lot Number 25CBG499; Medline SKU 60035431, Lot Number 25BBL338; Medline SKU 60035431, Lot Number 25ABS403; Medline SKU 60035431, Lot Number 25ABJ801; Medline SKU 60040706, Lot Number 25ABR093; Medline SKU 60061801, Lot Number 26ABB719; Medline SKU 60061801, Lot Number 25LBD922; Medline SKU 60061801, Lot Number 25KBB972; Medline SKU 60061801, Lot Number 25IBQ948; Medline SKU 60061801, Lot Number 25IBG717; Medline SKU 60061801, Lot Number 25ABF762; Medline SKU 60080349, Lot Number 26ABT007; Medline SKU 60080349, Lot Number 25KBA752; Medline SKU 60080349, Lot Number 25IBF307; Medline SKU 60080349, Lot Number 25EBF843; Medline SKU 60080349, Lot Number 25CBK717; Medline SKU 60080349, Lot Number 25CBA408; Medline SKU 60080349, Lot Number 24LBN469; Medline SKU 60100029, Lot Number 26BBH341; Medline SKU 60100029, Lot Number 26ABL391; Medline SKU 60100029, Lot Number 25LBS254; Medline SKU 60100029, Lot Number 25KBG811; Medline SKU 60100029, Lot Number 25JBB101; Medline SKU 60100029, Lot Number 25HBG368; Medline SKU 60100029, Lot Number 25EBR355; Medline SKU 60100029, Lot Number 24LBO386; Medline SKU 60100029, Lot Number 24LBN875; Medline SKU 60100599, Lot Number 25DBV070; Medline SKU 60100599, Lot Number 25DBR988; Medline SKU 60100599, Lot Number 25DBC935; Medline SKU 60100599, Lot Number 25CBR993; Medline SKU 60100599, Lot Number 25BBK878; Medline SKU 60100599, Lot Number 25ABL231; Medline SKU 60100599, Lot Number 24JBK614; Medline SKU 60100599, Lot Number 24FBT353; Medlin

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