Baxter DISCPAC Syringe Tip Caps Recalled for Potential Sterile Barrier Failure
Baxter is recalling DISCPAC Syringe Tip Caps due to potential packaging defect that may not maintain sterile barrier. The recall affects 8,500 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 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: FDA Class II recall with potential sterile barrier failure in medical device packaging. No illnesses or injuries have been reported. Per the severity rubric, theoretical hazards without reported harm score as High (3).
Plain-English summary
Baxter Healthcare Corporation is recalling Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack (REF H938677100). The recall is due to a potential failure of the packaging to maintain a sterile barrier for the tip caps. A compromised sterile barrier could allow contamination of the device prior to use.
Approximately 8,500 units are affected by this recall. Distribution includes the United States (nationwide), Australia, Finland, Germany, Spain, and the United Kingdom. All lots with UDI 00085412479873 are included.
Affected customers should consult the FDA and Baxter Healthcare Corporation for specific instructions regarding the recalled product.
The recalled product
- Product
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 8,500
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 (3)
- REF H938677100
- UDI 00085412479873
- ALL LOTS
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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