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RECOTHROM SPRAY KIT

BAXTER HEALTHCARE CORPORATION · Model ADS201802 · UDI-DI 05413765580970

KYZ Prescription

510(k) clearances

589

Adverse events (1 deaths)

Recalls

373

Facilities

Description

RECOTHROM SPRAY APPLICATOR KIT includes several components designed for topical application of Recothrom onto the bleeding site to aid hemostasis. The spray kit components and packaging are to be used in a sterile environment. The Spray Kit has been designed to be compatible with Recothrom, Thrombin topical (Recombinant) used in the acute care settings of a hospital.

Recalls

Date	Firm	Reason
2026-06-30	Boston Scientific Corporation	Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loo
2024-01-04	MEDLINE INDUSTRIES, LP - Northfield	Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be b
2023-12-04	Cardinal Health 200, LLC	Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
2022-12-07	MEDLINE INDUSTRIES, LP - Northfield	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
2018-02-06	Baxter Healthcare Corporation	Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
2017-12-19	Cook Inc.	Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable ga
2017-06-01	Shippert Medical Technologies	Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
2017-06-01	Shippert Medical Technologies	Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
2016-08-03	C.R. Bard, Inc.	Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
2016-08-03	C.R. Bard, Inc.	Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.