Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
FDA Recall Z-2952-2011 · Posted 2011-08-04
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Recalling FirmSpectranetics Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2011-07-18
Date Terminated2011-08-12
Product Quantity123 units
Reason for Recall
Packaging integrity may be compromised, thus sterility can not be assured.
Firm Action
Spectranetics sent an "PRODUCT RECALL NOTICE: EU SHIPMENTS OF TURBO-BOOSTER LASER GUIDE CATHETERS" letter dated July 15, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers.
The letter instructs customers to check their inventory and set aside affected product. Customers are to contact their sales representative for information on how to return the affected product and receive replacement product.
Further information is available at +011.49.719.447.2539.
Root Cause
Package design/selection
Distribution Pattern
Foreign Distribution-including the countries of Belgium, Cyprus, Germany, Greece, Italy, Spain, Switzerland, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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