CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report

Coseal Surgical Sealant Kit, Product recalled by Baxter Healthcare

Baxter Healthcare is recalling Coseal Surgical Sealant Kit, distributed nationwide in the US. The recall was initiated on 12 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesHA151038, HA151220, HA151037, HA151028, HA160114, HA160115, HA160222

Quantity recalled6,128 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-1840-2016
FDA event ID: 74139
Recalling firm: Baxter Healthcare, Hayward, CA
Classification: Class II
Status: Terminated
Recall initiated: 12 May 2016
FDA classified: 31 May 2016
Reported: 8 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Heart & Vascular Devices

Timeline

12 May 2016	Recall initiated by company
31 May 2016	Classified by FDA	+19 days
8 Jun 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

Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Where it was distributed

Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.

Which lots are affected?

HA151038, HA151220, HA151037, HA151028, HA160114, HA160115, HA160222

Where was it sold?

Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.

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

2 other products · FDA event 74139

This product is part of a recall event; the main page for the event is Coseal Surgical Sealant Kit, Product recalled by Baxter Healthcare.

Reported	Class	Recall	Company	Reason	Where
8 Jun 2016	CLASS II	Coseal Surgical Sealant Kit, Product recalled by Baxter Healthcare	Baxter Healthcare	Potency & Assay	Nationwide
8 Jun 2016	CLASS II	Coseal Surgical Sealant Kit, Product recalled by Baxter Healthcare	Baxter Healthcare	Potency & Assay	Nationwide

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All 573

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All 6,199

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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