Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues
Baxter Healthcare is recalling 6,804 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard involves a functional defect (incomplete dissolution affecting consistency) without reported injuries or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corp is recalling 6,804 units of COSEAL Surgical Sealant Kit, 4 mL (Product Code: 934071). 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 the reconstitution of the product. This issue 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 codes involved are HA160151, HA151205, HA151036, HA151035, and HA160229. Healthcare providers and facilities should check their inventory for these specific product codes and lot numbers.
The recalled product
- Product
- COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Manufacturer
- Baxter Healthcare Corp
- Affected units
- 6,804
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 (5)
- HA160151
- HA151205
- HA151036
- HA151035
- HA160229
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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