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

164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to — recall Z-2634-2018

U.S. FDA — Device Enforcement · United States · 2017-07-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2634-2018
Date of alert: 2017-07-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ICU Medical, Inc.
Product category: device
Product type: Devices

Reported risk: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

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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