Stylus Brand Angled Knife 52-2931, Slit Knife, double bevel, angled, full handle, 3.0mm 52-3231, Slit Knife, double bevel, angled, full handle, 3.2mm
FDA Recall Z-0948-04 · Posted 2004-07-20
Recalling FirmSurgical Specialties Puerto Rico, Inc.
Recall StatusTerminated
Product CodeHNN
Date Initiated2004-03-03
Date Terminated2004-09-10
Reason for Recall
Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
Firm Action
Customers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606.
Root Cause
Other
Distribution Pattern
Distribution was nationwide and internationally
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.