Product Wiki · Recalls · U.S. FDA — Device Enforcement

Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer… — recall Z-1852-2012

U.S. FDA — Device Enforcement · United States · 2012-05-16 · Class II

As described by U.S. FDA — Device Enforcement: Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 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 p

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1852-2012
Date of alert
2012-05-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
Reported risk: Difficulty in extending snare loop from the catheter
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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