Baxter Recalls FLOSEAL Special Applicator Tips Due to Plastic Formulation Error
Baxter Healthcare is recalling FLOSEAL Special Applicator Tips because an incorrect plastic formulation was used in the blue luer component.
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, but the source text does not report any injuries, illnesses, or specific functional failures, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corporation is recalling FLOSEAL Special Applicator Tips. The recall involves 46,908 pouches distributed nationwide to 48 states and the District of Columbia, as well as internationally to Australia, Korea, Taiwan, and Columbia. The affected products are identified by Product Code 1502186, Box Lot Numbers HA170718, HA170818, and HA170917, and Pouch Lot Numbers GR338160 and GR338384.
The recall was initiated because an incorrect plastic formulation was used in the manufacture of the blue luer component of the FLOSEAL malleable tips. The source text does not specify the exact nature of the hazard or any reported injuries or illnesses associated with this defect.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to Baxter Healthcare Corporation or the distributor in accordance with the recall instructions.
The recalled product
- Product
- FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 46,908
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)
- Product Code: 1502186
- Box Lot Numbers: HA170718
- HA170818
- and HA170917
- Pouch Lot Numbers: GR338160 and GR338384
Distribution
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