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

4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for in — recall Z-1185-2014

U.S. FDA — Device Enforcement · United States · 2013-11-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1185-2014
Date of alert: 2013-11-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smiths Medical ASD, Inc.
Product category: device
Product type: Devices

Reported risk: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

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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