Baxter Healthcare Corp.: 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.

Recall number

Z-2623-2011

Recalling firm

Baxter Healthcare Corp.

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.

Status

Terminated

Initiated

2011-05-17

Posted

2011-06-22

Terminated

2012-06-18

Reason

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

Root cause

Package design/selection

Action

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.

Quantity

4,800 units

Distribution

California and internationally to Japan and Australia

Lot, serial or model codes

product code 2N5601, lot number UR08C31068

510(k) numbers

["K962581"]

PMA numbers

not on file

Product code

FMG

Firm FEI

1416980

Firm city

Round Lake

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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