Baxter Syringe Tip Caps Recalled Due to Sterile Packaging Barrier Risk
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier. The product was distributed nationwide and internationally.
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 FDA medical device recall of sterile syringe tip caps with a potential loss of sterile barrier integrity. While no illnesses or injuries have been reported and the hazard is theoretical, the product is a risk-of-harm sterile medical device where packaging failure to maintain sterility poses a meaningful safety concern.
Plain-English summary
Baxter Healthcare Corporation is recalling 9,700 units of DISCPAC Syringe Tip Caps (Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100). The product was distributed worldwide, including throughout the United States, Australia, Finland, Germany, Spain, and the United Kingdom. All lots are affected.
The recall was issued due to a potential issue with the packaging, which may not maintain a sterile barrier for the tip caps.
Customers who have received the affected product should contact Baxter Healthcare Corporation for guidance and instructions on return or replacement.
The recalled product
- Product
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 9,700
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 H938676100
- UDI 00085412479859
- 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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