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E-Z CLEAN Non Stick Cautery Tip. Label reads in part:… recallZ-0486-2010 · Megadyne Medical Products, Inc. · initiated Oct 13, 2009

Terminated All recalls posted in December 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Megadyne Medical Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.

FDA root cause category: Error in labeling

What the company is doing

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.

Recall details

Recall number
Z-0486-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 13, 2009
Posted by the FDA
Dec 3, 2009
Recalling firm
Megadyne Medical Products, Inc.
Quantity
324 units
Product code
GEI
FDA submissions
K081791
Distribution
Worldwide Distribution -- United States (CA, FL, NE, LA, MT, OK, OR, PA, SC and UT) and New Zealand.

Product description

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.

Code information (models, lots, serial numbers)

Lot Number: 91469.

Other devices under the same FDA submission

20 devices cleared under K081791 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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