FDAFDA · Food and drugs·Recall number Z-2771-2016
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Published September 21, 2016 · Recall initiated: February 17, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- US Distribution to states of: NC, OH, FL, and MD.
- Lot
- Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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