Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0534-2018 — 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 uniq

U.S. FDA — Device Enforcement · United States · 2017-07-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0534-2018
Date of alert
2017-07-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10884527016990
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.