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

Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place. — recall Z-1234-2015

U.S. FDA — Device Enforcement · United States · 2015-02-05 · 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-1234-2015
Date of alert
2015-02-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zipline Medical
Product category
device
Product type
Devices
Reported risk: The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.