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

Vein & Vascular Pack - contains Devon Light Glove Used during surgery — recall Z-2003-2015

U.S. FDA — Device Enforcement · United States · 2015-04-20 · Class II

As described by U.S. FDA — Device Enforcement: Vein & Vascular Pack - contains Devon Light Glove Used during surgery

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-2003-2015
Date of alert
2015-04-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stradis Healthcare, LLC.
Product category
device
Product type
Devices
Recall status
Completed — the recalling firm has completed its actions
Initiated by
Voluntary: Firm initiated
Distribution
Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
Reported risk: Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
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.

Related

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.