Z-0657-2024Class II

Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072

Name: Z-0657-2024 Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
Creator: Baxter Healthcare Corporation
Published: 2023-12-06
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-12-06 / Open, Classified / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072 on 2023-12-06. FDA classified it as Class II and gives the reason as "Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0657-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-06
Posted: 2024-01-05
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
Product code: NBE Sealant, Polymerizing
Reason for recall: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Baxter issued an IMPORTANT PRODUCT INFORMATION to its consignees on 12/06/2023 via USPS first class mail. The notice explained the issue, potential hazard involved, and requested the following: Actions to be Taken by Customers: 1. Healthcare providers may continue to safely use the products listed above while following the associated Instructions for Use. 2. Cease any further distribution of the Cardiovascular Surgery marketing brochure for the products listed above. All copies of this marketing brochure should be promptly discarded. The brochure reference number, US-AS46-220001, can be found at the bottom of the last page of the brochure. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any inventory. Log in to the portal using the account number listed on the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed a copy of this brochure to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any copies of the brochure to other facilities, please distribute this notification to customers and check the associated box on the customer portal. For general questions, contact Baxter Healthcare Center for Service at 888-229-0001, betwe
Distribution: US Nationwide distribution.
Product codes and lots: All serial numbers a) Product code 934070, UDI/DI 5413765404610; b) Product code 934071, UDI/DI 5413765404627; c) Product code 934072, have no UDI/DI.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0657-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0656-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0657-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0658-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0659-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0660-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0661-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0662-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0663-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0664-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0665-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0666-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0667-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0668-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0669-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05

Product code NBE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)