Baxter DISCPAC Syringe Tip Caps Recalled for Compromised Sterile Barrier
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failure that could compromise the sterile barrier. The recall affects 602,340 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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard presents a potential risk to product sterility through packaging failure, meeting the criteria for Score 3 as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling Baxter DISCPAC Syringe Tip Caps (Self-Righting, Luer Slip, Yellow). The recall includes three product configurations: 25-pack (REF H93866025), 100-pack (REF H93866100), and 25-pack (REF H938690025), totaling approximately 602,340 units.
The recall was initiated due to a potential failure of the packaging to maintain a sterile barrier around the syringe tip caps. A compromised sterile barrier could affect the sterility and integrity of the caps during storage, handling, or use.
The affected products have been distributed worldwide, including throughout the United States and internationally to Australia, Finland, Germany, Spain, and the United Kingdom.
The recalled product
- Product
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H938690025
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Syringes / Caps
- Affected units
- 602,340
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 (7)
- a) REF H93866025
- UDI 00085412478845
- ALL LOTS
- b) REF H93866100
- UDI 00085412478852
- c) REF H938690025
- UDI 00085412479941
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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