Class 2 Device Recall Vistec TM XRay Detectable Sponges

• Date Initiated by Firm: July 17, 2017
• Create Date: February 08, 2018
• Recall Status: Terminated on September 14, 2018
• Recall Number: Z-0534-2018
• Recall Event ID: 78968
• Product Classification: Gauze/sponge, internal, x-ray detectable - Product Code GDY
• Product: Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.
• Code Information: Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997
• Recalling Firm/ Manufacturer: Covidien LP; 1430 Marvin Griffin Rd; Augusta GA 30906-3851
• For Additional Information Contact: 706-771-2140
• Manufacturer Reason for Recall: Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.
• FDA Determined Cause: Material/Component Contamination
• Action: Medtronic sent an Urgent Medical Device Recall letter dated July 17, 2017 to their customers via Federal Express or certified mail. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine, discontinue use and return affected product. Customers were instructed to acknowledge receipt of the Urgent Field Corrective Action Notice. For questions contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
• Quantity in Commerce: 33,280
• Distribution: U.S., Gov Accts, and foreign countries: PA, PR, CO.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.