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

Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of dra — recall Z-1084-2017

U.S. FDA — Device Enforcement · United States · 2016-11-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1084-2017
Date of alert: 2016-11-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Atrium Medical Corporation
Product category: device
Product type: Devices

Reported risk: Outer Packaging is not sterile

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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