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

Recall Z-1474-2021 — Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.

U.S. FDA — Device Enforcement · United States · 2021-03-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1474-2021
Date of alert: 2021-03-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smiths Medical ASD Inc.
Product category: device
Product type: Devices

Reported risk: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

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-1474-2021 — Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.

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