medical MODERATE Updated 2018-02-14

Covidien LP recalls Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ra

See all recalls from Covidien LP →

Recalled 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.

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

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.

Issued by

FDA

Affected States: PA, CO
Lot/Code Info: Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall