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Z-0605-2016 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0605-2016 was initiated by Baxter Healthcare Corp. on Nov 30, 2015 and is designated Class II. Reason for recall: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set. The recall status is terminated (terminated Oct 30, 2016). Affected quantity: 9264 units.

Recall Details

Product Type: Devices
Report Date: Jan 13, 2016
Initiation Date: Nov 30, 2015
Termination Date: Oct 30, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9264 units

Product Description

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.

Reason for Recall

Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

Distribution Pattern

US Nationwide Distribution and the country of Canada

Code Information

Lot Numbers: GR323998, GR325035, GR326082, and GR327965

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0605-2016
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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