Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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).
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- AVID Medical, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Product Codes/Lot Numbers:
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).
Distribution:
Distributed in: US, FL, IL, MO, MS, NC, NE, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1972-2026
Related Recalls
Halyard, Towel Six Pack. Kit Code: AMTS70-01.
AVID Medical
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Halyard, Pain Pack. Kit Code: AMPK48-01.
AVID Medical
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Halyard, Drape Pack. Kit Code: LMDP36-01.
AVID Medical
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.