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

Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injec — recall Z-1756-2018

U.S. FDA — Device Enforcement · United States · 2018-03-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1756-2018
Date of alert: 2018-03-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cook Inc.
Product category: device
Product type: Devices

Reported risk: Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.

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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