Z-0606-2016 Class II Terminated
FDA device recall Z-0606-2016 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: 9600 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
- 9600 units
Product Description
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. .
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: GR324012, GR325322, GR326769, and GF328518
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0606-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026