Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set and Minivolume Extension Set, product code 3C0108; An Rx sterile, nonpyrogenic fluid pathway; solution set: 58'', 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection sites and male Luer Lock adapter, stopcock extension set: 43'', 6.5 mL Vol with 2 injection sites and male luer adapter, and minivolume extension set: 6'', 0.4 mL Vol with male luer slip T-connector; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
FDA Recall Z-0654-06 · Posted 2006-03-24
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Reason for Recall
Firm Action
Root Cause
Other
Distribution Pattern
Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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