Device recall: COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive…

Class II FDA enforcement event 74139. Recall start date: 12 May 2016. Status in the FDA record: Terminated. Termination date: 23 Mar 2017.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Baxter Healthcare Corp started this device recall on 12 May 2016. The firm address in the FDA record is in Hayward, CA. FDA put the recall in Class II. FDA event 74139 has 3 product records. The first FDA enforcement report date is 8 Jun 2016. The record gives the status Terminated, with the termination date 23 Mar 2017.

FDA enforcement report The 3 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

Baxter Healthcare Corp, Hayward, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

3 product records in the event.

FDA event 74139: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1838-2016	COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.	274 units	Class II	Terminated	8 Jun 2016
Z-1839-2016	COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.	6,804 units	Class II	Terminated	8 Jun 2016
Z-1840-2016	COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.	6,128 units	Class II	Terminated	8 Jun 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 3Median of the firm: 1
Events of the firm on the register: 83

Other events of the firm

Other FDA enforcement events of Baxter Healthcare Corp
Initiated	Product (first record)	Type	Class	Records
1 Sep 2017	Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479	Device	Class II	1
12 Oct 2016	GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dial	Device	Class II	1
28 Sep 2016	sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 3	Device	Class II	3
24 Jun 2016	Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106	Device	Class II	1
23 May 2016	PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy	Device	Class II	1
21 Apr 2016	GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Devic	Device	Class II	5
12 Apr 2016	Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL,	Drug	Class II	1
16 Feb 2016	Automated peritoneal dialysis (APD) cycler	Device	Class II	1
5 Feb 2016	0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Produc	Drug	Class II	1
21 Jan 2016	0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter	Drug	Class I	4

Baxter Healthcare Corp: all 83 events

Official channels

FDA enforcement report Z-1838-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 74139. https://recallregister.com/fda/ii/74139/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
What quantity of product is in FDA event 74139?: The event has 3 product records. The first record gives this quantity: 274 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.