Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.

FDA device recall Z-0891-2013 · posted 2013-02-27 · Terminated

Recall details

Recalling firm

Myco Medical Supplies Inc

Reason for recall

Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.

Action taken

MYCO Medical sent an Advisory Notice dated February 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers wsere instructed to review their inventory for the affected product and immediately quarantine the affected product per their internal procedures. Customers were also instructed to complete the attached Material for Return form and return to MYCO via email QA@mycomedical.com or fax to 919-800-3919. Customers were have the returned material packaged and ready for UPS to pick up at their location. If product was shipped to other customers, customers were asked to contact a MYCO Customer Service Representative with the additional customer's contact and ship-to information. Customers with questions were instructed to call 919-460-2535. For questions regarding this recall call 919-460-2535, ext 105.

Root cause

Packaging

Status

Terminated

Product code

GDX

Quantity affected

110,768 scalpels in individual pouches

Distribution

Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada

Date initiated

2013-02-07

Date posted

2013-02-27

Date terminated

2013-07-09

Location

Cary, NC