E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
FDA Recall Z-0486-2010 · Posted 2009-12-03
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Recalling FirmMegadyne Medical Products, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2009-10-13
Date Terminated2010-02-17
Product Quantity324 units
Reason for Recall
Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.
Firm Action
A notification letter dated October 13, 2009 was sent to the first level consignees. Consignees were instructed to examine their stock, remove affected product and contact Megadyne Customer Service at 1-800-747-6110 (United States) or 1-801-576-9669 for product return instructions.
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution -- United States (CA, FL, NE, LA, MT, OK, OR, PA, SC and UT) and New Zealand.
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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