Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues
Baxter Healthcare is recalling 274 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (incomplete dissolution) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corp is recalling 274 units of COSEAL Surgical Sealant Kit, 2 mL (Product Code: 934070). The product is used in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. The recall was initiated due to a potential for incomplete dissolution of the polyethylene glycol (PEG) component during reconstitution, which may affect the consistency of the hydrogel formation during use.
The affected units were distributed nationwide in the United States, including Puerto Rico, as well as in the Bahamas, Canada, and Singapore. The specific lot code for the recalled product is HA160136.
Healthcare providers and patients should stop using the affected COSEAL Surgical Sealant Kits and contact Baxter Healthcare Corp for further instructions or a replacement.
The recalled product
- Product
- COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Manufacturer
- Baxter Healthcare Corp
- Affected units
- 274
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- HA160136
Distribution
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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