Enforcement Report - Week of June 27, 2012
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Product Detail
| Product Description | Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop |
|---|---|
| Recall Number | Z-1850-2012 |
| Classification | Class II |
| Code Info | Lot Numbers: 14951476, 14951479, 14987882,15068203 |
| Product Distributed Qty | 2760 units |
| Reason For Recall | Difficulty in extending snare loop from the catheter |
Event Detail
| Event Id | 61935 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Boston Scientific Corporation |
| City | Marlborough |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-16 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland |
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