Baxter DISCPAC Syringe Tip Caps recalled for packaging sterility concerns
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failures that could compromise the sterile barrier on 10,140 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: Although classified as FDA Class II, the source states only a potential sterile barrier compromise with no reported illnesses or injuries. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the maximum score is 3. Syringe tip caps are risk-of-harm medical devices; sterile barrier failure could lead to contamination and infection, justifying a 'High' rating.
Plain-English summary
Baxter Healthcare Corporation is recalling DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White (Reference number H938671100, UDI 00085412479750). The recall affects 10,140 units that have been distributed worldwide, including throughout the United States and internationally in Australia, Finland, Germany, Spain, and the United Kingdom.
The recall is due to a potential for the product packaging to fail in maintaining a sterile barrier for the syringe tip caps. These medical devices are used in healthcare settings to maintain the sterility of syringes prior to use. A compromised sterile barrier could allow contamination of the device prior to use.
No illnesses or injuries have been reported to date in connection with this issue. The FDA has classified this as a Class II recall, indicating potential for adverse health consequences but without confirmed reports of harm.
The recalled product
- Product
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 10,140
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 (2)
- REF H938671100
- UDI 00085412479750
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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