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U.S. Department of Health and Human Services

Class 2 Device Recall Vistec TM XRay Detectable Sponges

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  Class 2 Device Recall Vistec TM XRay Detectable Sponges see related information
Date Initiated by Firm July 17, 2017
Create Date February 08, 2018
Recall Status1 Terminated 3 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 2		 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.
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