—#95361

Product

Baxter Three-Way Large Bore Stopcock with Rotating Male Luer Lock Adapter; a sterile, nonpyrogenic fluid pathway; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 2C6201. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device. The stopcock was sold alone and as a component of the following I.V. Administration Sets: a) product code 1C8471, Baxter Interlink System Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 44", Vol. 5.9 mL; b) product code 2N5600, Baxter Interlink System Large Bore 3-Way Stopcock with Rotating Male Luer Lock, Vol. 0.7 mL; c) product code 3C0114, Baxter Interlink System Continu-Flo Solution Set, 66", 2-Port Manifold with Check Valves, and Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 40", Vol. 5.6 mL; d) product code 3C0180, Baxter Clearlink System Non-DEHP Continu-Flo Solution Set, 108", Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 30", Vol. 3.9 mL, and Extension Set, 7", 0.9 mL; e) product code 3C0021, Baxter Interlink System Continu-Flo Solution Set, 65" with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 61", Vol. 9.1 mL; f) product code 3C0174, Baxter Interlink System Buretrol Solution Set, 58", Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 43", Vol. 6.1 mL, and Minivolume Extension Set, 6", 0.6 mL; g) product code 3C0098, Baxter Interlink System Solution Set, 30", Extension Set, 44", Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 29", Vol. 3.9 mL, 3-Port Manifold with Check Valves and Extension Set, 7"; h) product code 3C0090, Baxter Interlink System Continu-Flo Solution Set, 107" with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 38", Vol. 5.8 mL; i) product code 3C0175, Baxter Interlink System Buretrol Solution Set, 56", Two Large Bore 3-Way Stopcocks with Rotating Male Luer Lock Minivolume Extension Set, 53", 1.5 mL;

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K962581
Affected lot / code info: all lots of product codes 2C6201, 1C8471, 2N5600, 3C0114, 3C0180, 3C0021, 3C0174, 3C0098, 3C0090 and 3C0175

Why it was recalled

Rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy.

Root cause (FDA determination)

Device Design

Action the firm took

Safety Alert letters dated October 28, 2010 were mailed via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, on the same date, informing them that rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy. The accounts were requested to post the enclosed attachment, which illustrates the correct direction to turn the handle of the stopcock, where the stopcocks/sets are dispensed. The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at (847) 270-5457. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. The Baxter Field Corrective Action Gatekeepers were also notified of this action via e-mail on 10/27/10, and instructed to notify their customers and ministries of health of the recall. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Worldwide distribution: USA and countries including Puerto Rico, Guam and American Samoa, and internationally to Canada, Bermuda, Jamaica, Guatemala, Panama, Bahrain, United Kingdom, Hungary, Lebanon, Pakistan, Saudi Arabia and New Zealand.

Timeline

Recall initiated: 2010-10-28
Posted by FDA: 2010-12-09
Terminated: 2012-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95361. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.