Baxter Y-Type Spike Adapter Recalled for Potential Particulate Matter
Baxter Healthcare is recalling Y-Type Spike Adapters due to the potential presence of dark loose particulate matter on the spike.
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 medical device with a risk of particulate matter entering the vascular system, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corp. is recalling Baxter Y-Type Spike Adapters, 7" (18 cm), catalog number 1C8433. The recall involves 9,264 units distributed nationwide in the United States and in Canada. The specific lot numbers affected are GR323998, GR325035, GR326082, and GR327965.
The recall was initiated because of the potential for dark loose particulate matter, measuring 400 microns or smaller, to be present on the spike of the spike adapter or solution set. These adapters are used for the administration of fluids from a container into a patient's vascular system through a vascular access device.
Healthcare facilities and consumers who have these specific products should stop using them and contact Baxter Healthcare Corp. for further instructions or a return.
The recalled product
- Product
- Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 9,264
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 (4)
- Lot Numbers: GR323998
- GR325035
- GR326082
- and GR327965
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corp. 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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