Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotating Male Luer Lock; a sterile, n

FDA device recall Z-2623-2011 · posted 2011-06-22 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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

Action taken

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.

Root cause

Package design/selection

Status

Terminated

Product code

FMG

Quantity affected

4,800 units

Distribution

California and internationally to Japan and Australia

Date initiated

2011-05-17

Date posted

2011-06-22

Date terminated

2012-06-18

Location

Round Lake, IL

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