Z-2623-2011

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

Name: Z-2623-2011 Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotating Male Luer Lock; a...
Creator: Baxter Healthcare Corp.
Published: 2011-05-17
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-05-17 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of 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... on 2011-05-17. The reason FDA records is "There is the potential for pinholes and tears in the individual packaging of the stopcocks, compromising the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2623-2011
Status: Terminated
Initiated: 2011-05-17
Posted: 2011-06-22
Terminated: 2012-06-18
Recalling firm: Baxter Healthcare Corporation
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.
Product code: FMG Stopcock, I.V. Set
Reason for recall: There is the potential for pinholes and tears in the individual packaging of the stopcocks, compromising the sterility of the product.
Root cause tag: packaging
FDA 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 in commerce: 4,800 units
Distribution: California and internationally to Japan and Australia
Product codes and lots: product code 2N5601, lot number UR08C31068

Product code FMG

K962581Class IIStopcock Manifold GangsBaxter Healthcare Corp / cleared 1996-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)