Baxter Syringe Tip Caps Recalled Due to Sterile Packaging Barrier Failure
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging defects that may not maintain sterile barriers. The recall affects approximately 63,190 units distributed worldwide.
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: This is a Class II recall with no reported illnesses or injuries. The hazard is described as potential and theoretical (packaging may not maintain sterile barrier), and the recall is precautionary in nature. Per the rubric, when a hazard is theoretical with no reported incidents, the score is at most 3; this case fits the criteria for a precautionary recall at Score 2.
Plain-English summary
Baxter Healthcare Corporation is recalling approximately 63,190 units of DISCPAC Syringe Tip Caps (Self-Righting, Luer Slip, Orange) due to a potential defect in product packaging. The issue involves the packaging's ability to maintain a sterile barrier protecting the tip caps.
The affected products include two pack sizes: the 25-pack (REF H93867025) and 100-pack (REF H93867100). All lots of both products are included in this recall. The products have been distributed worldwide, including throughout the United States and internationally in Australia, Finland, Germany, Spain, and the United Kingdom.
Healthcare providers and other recipients of these products should stop using the affected syringe tip caps and contact Baxter Healthcare Corporation for replacement or return instructions.
The recalled product
- Product
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 63,190
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)
- a) REF H93867025
- UDI 00085412478869
- ALL LOTS
- b) REF H93867100
- UDI 00085412478890
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Baxter Healthcare Corporation 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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