Z-0534-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- July 17, 2017
- Termination Date
- September 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,280
Product Description
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.
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.
Distribution Pattern
U.S., Gov Accts, and foreign countries: PA, PR, CO.
Code Information
Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997