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

Recall Z-1527-2018 — EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler

U.S. FDA — Device Enforcement · United States · 2018-04-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1527-2018
Date of alert: 2018-04-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Covidien LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10884521047518

Reported risk: There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.

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.

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