Baxter Recalls Dual Luer Lock Caps Due to Loose Particulate Matter
Baxter Healthcare is recalling specific lots of Dual Luer Lock Caps because loose particulate matter was found in the packaging, posing a risk of embolic events.
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: The recall involves a risk-of-harm product (medical device) where the hazard (embolic events) is explicitly stated, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria.
Plain-English summary
Baxter Healthcare Corp. is recalling 628,992 units of Dual Luer Lock Caps, specifically lots 10043 and 10044. These devices are intended to be used as caps for male or female Luer ports on medical devices such as manifolds, stopcocks, or sets.
The recall was initiated due to the discovery of loose particulate matter in the packaging. The source text notes that if this particulate matter enters the fluid path from the Luer lock caps, it may result in embolic events.
The affected products were distributed nationwide in the United States and in Canada. Healthcare facilities and consumers should stop using the affected lots and contact Baxter Healthcare Corp. for further instructions.
The recalled product
- Product
- Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Luer Lock Caps
- Affected units
- 628,992
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)
- 10043
- 10044
Distribution
Distributed nationwide across the United States.
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