—#100391

Product

Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotating Male Luer Lock; a sterile, nonpyrogenic fluid pathway; product code 2N5601. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K962581
Affected lot / code info: product code 2N5601, lot number UR08C31068

Why it was recalled

There is the potential for pinholes and tears in the individual packaging of the stopcocks, compromising the sterility of the product.

Root cause (FDA determination)

Package design/selection

Action the firm took

Baxter Urgent Product Recall letters dated May 17, 2011 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 potential pinholes and tears in the individual packaging could compromise the sterility of the stopcock. The accounts were requested to locate and remove all affected inventory from their facility and return it to Baxter after calling Baxter Healthcare Center for Service at 1-888-229-0001 to obtain the returned goods authorization The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. 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. The Baxter Field Corrective Action Gatekeepers were also notified of this action via e-mail on 5/17/11, and instructed to notify their customers and ministries of health of the recall.

Recalling firm

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

Distribution

Distribution pattern: California and internationally to Japan and Australia

Timeline

Recall initiated: 2011-05-17
Posted by FDA: 2011-06-22
Terminated: 2012-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100391. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.