CLASS II Device recall · Reported 28 Apr 2021 · FDA Enforcement Report

Medex Pressure Injector Line w/Rot (1200psi) NS recalled

Smiths Medical ASD is recalling Medex Pressure Injector Line w/Rot (1200psi) NS, distributed nationwide in the US. The recall was initiated on 31 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 3946994

Quantity recalled500 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1481-2021
FDA event ID: 87647
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 31 Mar 2021
FDA classified: 21 Apr 2021
Reported: 28 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

31 Mar 2021	Recall initiated by company
21 Apr 2021	Classified by FDA	+21 days
28 Apr 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.

Where it was distributed

Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number 3946994

Where was it sold?

Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 87647

This product is part of a recall event; the main page for the event is Tubing with male luer lock adapter (Component) recalled.

Reported	Class	Recall	Company	Reason	Where
28 Apr 2021	CLASS II	Tubing with male luer lock adapter (Component) recalled	Smiths Medical ASD	Other	Nationwide
28 Apr 2021	CLASS II	Left Heart Kit recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
28 Apr 2021	CLASS II	Stopcock rotator (Component) recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
28 Apr 2021	CLASS II	LogiCal Monitoring Set recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
28 Apr 2021	CLASS II	LogiCal Left Heart Kit recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
28 Apr 2021	CLASS II	Manifold rotator (Component) recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
28 Apr 2021	CLASS II	Gang Cath Lab Set recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
28 Apr 2021	CLASS II	High Pressure Rotator (Component) recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
28 Apr 2021	CLASS II	High Pressure Tubing recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
28 Apr 2021	CLASS II	Angiographic Kit W/mx123-3mr Manifold recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide
28 Apr 2021	CLASS II	Mark 910 LogiCal recalled by Smiths Medical ASD	Smiths Medical ASD	Other	Nationwide

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All 284

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14 May 2025Device	CLASS I	Cadd-Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Device Malfunction	Nationwide
14 May 2025Device	CLASS I	Cadd-Solis Hpca Ambulatory Infusion Pump recalled by Smiths Medical ASD	Smiths Medical ASD	Device Malfunction	Nationwide

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide