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

regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure — recall Z-0059-2016

U.S. FDA — Device Enforcement · United States · 2015-04-22 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0059-2016
Date of alert: 2015-04-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Resource Optimization & Innovation Llc
Product category: device
Product type: Devices

Reported risk: The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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