Device Recall Technocut Plus,Sterile Single Use Safety Scalpel. 의 리콜

Recall

64434

Class 2

Z-0891-2013

2013-02-07

2013-02-27

Terminated

United States

2013-07-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116137

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

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.