Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0606-2016·Announced 2016-01-13

Baxter INTERLINK Y-Type Solution Set Recalled for Particulate Matter

Baxter Healthcare is recalling INTERLINK Y-Type Solution Sets due to potential dark particulate matter on the spike adapter.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is particulate matter, which is a contamination issue, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Baxter Healthcare Corp. is recalling 9,600 units of the INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, catalog number C8581. The recall is due to a potential for dark loose particulate matter, measuring 400 microns or smaller, on the spike of the spike adapter or solution set.

The affected products were distributed nationwide in the United States and in Canada. The specific lot numbers involved in this recall are GR324012, GR325322, GR326769, and GF328518. These devices 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 should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product: Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. .
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — Infusion Sets
Hazard: contamination
particulate-matter
Affected units: 9,600

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: GR324012
GR325322
GR326769
and GF328518

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.

See all 3 products in this recall →

Same manufacturer · Baxter Healthcare Corp.

See all →

High
Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
Moderate
Baxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
Moderate
Baxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
Moderate
Baxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
High
Baxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16

Same hazard · contamination