Boston Scientific Corporation: IceRod" He-Thaw Prostate Cryoablation Kit

Is my product affected?

IceRod" He-Thaw Prostate Cryoablation Kit

• UPC 7290104830099
• UPC 7290104830105

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation has recalled 115 units of the IceRod He-Thaw Prostate Cryoablation Kit nationwide due to a complaint trend regarding needle shaft gas leaks. The affected units are identified by UPN FPRPR4570 and specific batch numbers ranging from G5063 to P2411.

The source does not specify a remedy or the actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Complaint trend regarding needle shaft gas leaks.

Details from the source

Reason for recall: Complaint trend regarding needle shaft gas leaks. Distribution: Nationwide Quantity: 115 units Lot/code info: UPN: FPRPR4570 UDIs: 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099 Batch Numbers:G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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