The Recall Desk
SevereFDA (Devices)·Z-1474-2021·Announced 2021-04-28

Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is Class II, and the defect involves structural integrity (incomplete welds) in medical devices used for pressure monitoring, which fits the 'Severe' criteria for structural defects.

Plain-English summary

Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, and Tubing, as well as Medex LogiCal Kits. These components are used in various cardiac kits, including pressure monitoring devices and interventional imaging devices.

The recall was initiated because the affected products may have been manufactured with insufficient or incomplete welds. The recall covers 400 devices from Lot Number 4007165. Distribution was US nationwide including Puerto Rico, as well as Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

Healthcare facilities and consumers should stop using the affected products and contact Smiths Medical ASD Inc. for further instructions.

The recalled product

Product
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.
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Cardiac Monitoring
Hazard
Affected units
400

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 4007165

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

See all →

Same hazard · structural defect

See all →