Baxter Syringe Tip Caps Recalled Due to Incorrect Labeling
Baxter is recalling DISCPAC syringe tip caps that are mislabeled as self-righting when they do not possess this capability, risking improper use in medical procedures.
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: FDA Class II recall for a labeling defect with no reported injuries or illnesses. The hazard is characterized as a labeling error with no documented harm, which corresponds to the rubric criterion for moderate-severity labeling errors.
Plain-English summary
Baxter Healthcare Corporation is recalling DISCPAC Syringe Tip Caps (Luer slip, yellow, REF H93866100) due to incorrect product labeling. The caps are labeled as "self-righting" but do not have this functionality, creating a risk of improper use in clinical and medical settings.
Approximately 5,500 DISCPACs (100 caps per package) are affected. The impacted lot numbers are 60268365, 60268609, and 60268610, with an expiration date of October 31, 2023. Affected product has been distributed in the United States (Florida, Georgia, Illinois, Indiana, Missouri, Pennsylvania, Texas, and Virginia) and internationally (Canada, Austria, Germany, Netherlands, Qatar, Saudi Arabia, and Spain).
No injuries or illnesses have been reported to date. Healthcare facilities using these caps should immediately discontinue use of the affected lots and contact Baxter Healthcare Corporation for replacement product.
The recalled product
- Product
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
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)
- Lot numbers 60268365
- 60268609
- 60268610
- exp. date 10/31/2023
- UDI 0085412478852.
Distribution
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