Baxter Syringe Tip Caps Recalled for Potential Sterile Barrier Failure
Baxter Healthcare Corporation is recalling 168,390 units of DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier, creating a contamination risk.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving a medical device (syringe tip caps) with direct risk of harm from potential contamination. No illnesses or injuries have been reported and the hazard is theoretical, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 168,390 units of DISCPAC Syringe Tip Caps (green, self-righting, Luer Slip design) in 25-pack and 100-pack configurations. The affected product reference numbers are H93869025, H938674100, and H93869100, with all lot numbers included in the recall.
The packaging for these syringe tip caps may fail to maintain a sterile barrier. This defect creates a potential contamination risk, as tip caps are designed to protect syringe tips from microbiological contamination during storage and use.
The recalled products were distributed worldwide, including to the United States and internationally to Australia, Finland, Germany, Spain, and the United Kingdom. Healthcare facilities and medical professionals who have received these products should stop using them and contact Baxter Healthcare Corporation for instructions on returns or replacements.
The recalled product
- Product
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H93869100
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 168,390
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 (10)
- a) 25 pack
- REF H93869025
- UDI 00085412479965
- ALL LOTS
- b) 100 pack
- REF H938674100
- UDI 00085412479811
- c) 100 pack
- REF H93869100
- UDI 00085412478944
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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