Recall Z-0606-2016— Baxter Healthcare Corp.
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2015-11-30, terminated 2016-10-30. It names one FDA 510(k) clearance: K860272. 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. .. Reason: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set..
- Recalling firm
- Baxter Healthcare Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-30
- Terminated
- 2016-10-30
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.