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

Administration Set, Sterile recalled by Zyno Medical

Zyno Medical is recalling 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 codesB2-70071-DF Lot Codes: 14015279 14026620 14046841 14055191 14055786 14056225 14085743 14085742 15035297 15045941 15045940 15046600 15075275 15075835 15076761 15085107 15086621 15095200 15095647 15097179 15105595 B2-70071-DF-120 lot codes: 15066912 15075253 15075990 15076261 15076304

Quantity recalled78063 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-2895-2016
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: Packaging Defects
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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) 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

Why was it recalled?

Administration Set potential filter leaking

Which lots are affected?

B2-70071-DF Lot Codes: 14015279 14026620 14046841 14055191 14055786 14056225 14085743 14085742 15035297 15045941 15045940 15046600 15075275 15075835 15076761 15085107 15086621 15095200 15095647 15097179 15105595 B2-70071-DF-120 lot codes: 15066912 15075253 15075990 15076261 15076304

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 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

3 other products · FDA event 74892

This product is part of a recall event; the main page for the event is Administration Set, Sterile recalled by Zyno Medical.

Reported	Class	Recall	Company	Reason	Where
5 Oct 2016	CLASS II	Administration Set, Sterile recalled by Zyno Medical	Zyno Medical	Packaging Defects	Nationwide
5 Oct 2016	CLASS II	Administration Set Sterile recalled by Zyno Medical	Zyno Medical	Packaging Defects	Nationwide
5 Oct 2016	CLASS II	Administration Set, Sterile recalled by Zyno Medical	Zyno Medical	Packaging Defects	Nationwide

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

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide