Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F
FDA Recall Z-1111-05 · Posted 2005-08-10
Recalling FirmMedtronic Neurosurgery
Recall StatusTerminated
Product CodeGWG
Date Initiated2005-07-05
Date Terminated2008-06-26
Product Quantity79
Reason for Recall
Cracked hubs/handles and/or improper peeling of the sheath during use.
Firm Action
Firm sent recall letters by Fedex on July 5, 2005 to all customers.
Root Cause
Other
Distribution Pattern
Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, 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.