Device 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.
Z-0534-2018
Product summary
- Firm
- Covidien LP
- Event
- Event 78968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,280
- Official record key
device-enforcement:Z-0534-2018
Official wording
Reason: 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.
Code information: Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997
Distribution pattern: U.S., Gov Accts, and foreign countries: PA, PR, CO.
Derived failure modes
-
Unknown
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.