FDA-Device2016-09-07Class II
Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Baxter Healthcare Corp.
Hazard
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
Sold states
Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally to Canada.
Affected count
15,257 units
Manufactured in
Route 120 And Wilson Rd, N/A, Round Lake, IL, United States
Products
Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2687-2016Don't want to check this manually?
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