Baxter DISCPAC Syringe Tip Caps recalled due to sterile barrier failure
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because packaging may not maintain a sterile barrier. Affected units were distributed worldwide including the US, Australia, Finland, Germany, Spain, and the UK.
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 an FDA Class II recall for a potential sterile barrier failure in medical device packaging. No illnesses or injuries have been reported. The hazard poses a theoretical risk of microbial contamination but has not yet resulted in patient harm.
Plain-English summary
Baxter Healthcare Corporation is recalling specific batches of DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip in dark blue. The recall affects two product configurations: the 25-unit pack (REF H938693025) and the 100-unit pack (REF H938673100). A total of 24,320 units have been distributed.
The company identified a potential issue where the product packaging may not maintain a sterile barrier for the tip caps. Syringe tip caps must remain sterile to prevent microbial contamination when used in clinical or medical settings. Compromised packaging could allow contaminants to reach the sterile surface.
The affected products were distributed worldwide, including throughout the United States, Australia, Finland, Germany, Spain, and the United Kingdom. All lots of both product configurations are included in this recall.
Customers and healthcare facilities in possession of these products should stop using them and contact their Baxter distributor or the company directly for instructions on product return and replacement. No illnesses or injuries related to this issue have been reported to date.
The recalled product
- Product
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 24,320
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) 25 pack REF H938693025
- UDI 00085412479965
- ALL LOTS
- b) 100 pack REF H938673100
- UDI 00085412479798
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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