Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.
FDA Recall Z-0843-06 · Posted 2006-05-06
Recalling FirmCelsion Corporation, Inc.
Recall StatusTerminated
Product CodeMEQ
Date Initiated2006-03-22
Date Terminated2007-02-07
Product Quantity1515 kits
Reason for Recall
Surgical treatment kits containing medical device components were mislabeled with extended expiration dates.
Firm Action
The recalling firm notified the contract distributor on 2/17/06 to cease shipments. The distributor subsequently notified accounts on 3/22/06 with lot and shipment specific recall letters. The letters advised that consignees discontinue use of the affected lots for return to the distributor. Consignees were requested to return the reply verification form enclosed.
Root Cause
Other
Distribution Pattern
Products were distributed to one distributor in MA and eight medical device users in MA, IL, NJ, FL, NY, CO, OH, and MI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.