Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0534-2018 · Posted None

Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeGDY
Date Initiated2017-07-17
Date Terminated2018-09-14
Product Quantity33,280

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.

Firm 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.

Root Cause

Material/Component Contamination

Distribution Pattern

U.S., Gov Accts, and foreign countries: PA, PR, CO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑