United StatesHalyard cardiac/catheterization procedure kits — including Halyard CARDIAC CATH PACK and related kits with model numbers EAMC1000-05, WAFB208-02, DRCC36, SHND401-04, SHND401-05, SACL75AM, SACL75-01, SELF131-05, UINR44-01, SLPC34-01/SLPC34-02, SAMM066-15, and VMCD029 — are affected; specific lot/UDI numbers are listed in the notice. They were recalled due to a potential for the Medline syringe rotating adaptor to unwind during use, which may cause a loose connection or full disconnection between the syringe and manifold. These kits were distributed in the United States to FL, IL, MO, MS, NC, NE, and TX.
What's being recalled
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Halyard CATH LAB kit. Model Number: SACL75AM.
Halyard CATH LAB kit. Model Number: SACL75-01.
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Recalling firm: AVID Medical, Inc., Toano, VA, United States.
How to identify it
1. Model Number: EAMC1000-05. UDI-DI (Kit Lot Numbers): 10809160377314 (1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159). 2. Model Number: WAFB208-02. UDI-DI (Kit Lot Numbers): 10809160424759 (1615954, 1653009). Model Number: DRCC36. UDI-DI (Kit Lot Numbers): 10809160469088 (1659651). 1. Model Number: SHND401-04. UDI-DI (Kit Lot Numbers): 10809160395615 (1577749, 1577750, 1590780, 1590782, 1590783, 1590784, 1590785, 1590833, 1591141, 1591142, 1597561, 1600738, 1613343, 1622356, 1631890, 1643855, 1643856, 1643860, 1644853, 1645163, 1647458, 1647459, 1647460, 1650983, 1652365, 1652366). 2. Model Number: SHND401-05. UDI-DI (Kit Lot Numbers): 10809160491294 (1652367, 1668844, 1668845, 1668846, 1669188, 1669189, 1669504, 1669506, 1669507, 1671312, 1671313, 1671314, 1671315, 1671316). Model Number: SACL75AM. UDI-DI (Kit Lot Numbers): 10809160413586 (1599684, 1601393). Model Number: SACL75-01. UDI (Kit Lot Numbers): (01)20809160481377(17)280520(10)341730(30)004(241)UINR44-01 (341730), (01)20809160481377(17)280623(10)341742(30)004(241)SACL75-01 (341742), (01)20809160481377(17)280609(10)345855(30)004(241)SACL75-01 (345855), (01)20809160481377(17)280609(10)345863(30)004(241)SACL75-01 (345863). Model Number: SELF131-05. UDI-DI (Kit Lot Numbers): 10809160408650 (1611688, 1611689, 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656582, 1656581, 1659713, 1670884, 1670885, 1671950). Model Number: UINR44-01. UDI (Kit Lot Number): (01)20809160484439(17)280201(10)340135(30)004(241)UINR44-01 (340135), (01)20809160484439(17)280201(10)340136(30)004(241)UINR44-01 (340136), (01)20809160454439(17)280201(10)340352(30)004(241)UINR44-01 (340352), (01)20809160484439(17)280201(10)349076(30)004(241)UINR44-01 (349076). 1. Model Number: SLPC34-01. UDI-DI (Kit Lot Numbers): 10809160450963 (1640169, 1641409, 1641410, 1641411, 1641412, 1641413, 1641414, 1641415, 1645684); 10809160459904 (1649576, 1660882, 1660883…
The hazard
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US distribution to FL, IL, MO, MS, NC, NE, TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)