Recall Z-0534-2018— Covidien LP
Class II · Terminated
Class II FDA medical device recall by Covidien LP, initiated 2017-07-17, terminated 2018-09-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Covidien LP
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-17
- Terminated
- 2018-09-14
- Firm location
- Augusta, GA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.