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

Recall Z-1730-2015 — Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

U.S. FDA — Device Enforcement · United States · 2015-05-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1730-2015
Date of alert: 2015-05-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smiths Medical Asd Inc
Product category: device
Product type: Devices

Reported risk: Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.

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.

Recall Z-1730-2015 — Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

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