CLASS II Device recall · Reported 5 Oct 2016 · FDA Enforcement Report

Administration Set, Sterile recalled by Zyno Medical

Zyno Medical is recalling Zyno Medical Administration Set, Sterile, distributed nationwide in the US. The recall was initiated on 29 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: 14015257 14016574 14026116 14055563 14056558 14056578 14056564 14097009 14105233 14105981 14106122 14115694 14116060 14116061 15035164 15036531 15036532 15066217 15086619 15096764 15096765 15096843 15105499

Quantity recalled78069 sets

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-2894-2016
FDA event ID: 74892
Recalling firm: Zyno Medical, Natick, MA
Classification: Class II
Status: Terminated
Recall initiated: 29 Jul 2016
FDA classified: 27 Sep 2016
Reported: 5 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

29 Jul 2016	Recall initiated by company
27 Sep 2016	Classified by FDA	+60 days
5 Oct 2016	Published in enforcement report	+8 days

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

Reason for recall

Administration Set potential filter leaking

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Is Administration Set, Sterile recalled?

Yes. Zyno Medical recalled Administration Set, Sterile on 29 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2894-2016.

Why was it recalled?

Administration Set potential filter leaking

Which lots are affected?

Lot Code: 14015257 14016574 14026116 14055563 14056558 14056578 14056564 14097009 14105233 14105981 14106122 14115694 14116060 14116061 15035164 15036531 15036532 15066217 15086619 15096764 15096765 15096843 15105499

Where was it sold?

US Nationwide Distribution

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

More recalls from Zyno Medical

All 16

Reported	Class	Recall	Company	Reason	Where
18 Jun 2025Device	CLASS I	Z-800F Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800W Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800WF Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800 Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
4 Dec 2024Device	CLASS III	Z-800 Infusion System Z-800WF recalled by Zyno Medical	Zyno Medical	Device Malfunction	8 states

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