FDAFDA · Food and drugs·Recall number Z-0665-2021
IceRod" 1.5 i-Thaw" Cryoablation Needle
Published December 30, 2020 · Recall initiated: November 18, 2020
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaint trend regarding needle shaft gas leaks.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Nationwide
- Lot
- UPN: FPRPR4009 UDIs: 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204 Batch Numbers: U1362, U1217, U0957, U0283, U0282, U0087, T0819, T0392, A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, A1329
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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