FDA Recall Terminated

Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH non-absorbable braided nylon sutures Material 8886199362 Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.

Recall: Z-2823-2011 · Initiated June 3, 2011

Recall

Recall Number: Z-2823-2011
Event Number: 59104
FEI Number: 1219930
Product Code: GAP
Status: Terminated
Root Cause: Equipment maintenance
Initiated: June 3, 2011
Posted: July 15, 2011
Terminated: February 10, 2014
Address: LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

Description

Reason

Potential for the sterile barrier to be breached compromising the sterility of the product

Action

Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product. Customers were instructed to contact Covidien Customer Service at [email protected] or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product. Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore

Quantity

5496 units