—#102086

Product

Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2N3375 Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K925126
Affected lot / code info: product code 2N3375, lot number UR09H05029, expiration date 8/25/2014.

Why it was recalled

Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.

Root cause (FDA determination)

Packaging

Action the firm took

The firm, Baxter, sent an "Urgent Product Recall" letter dated July 6, 2011 via first class mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from their facility; call Baxter Healthcare's Center for Service at 1-888-229-0001 between 7:00 am and 6:00 pm Central Time, Monday through Friday to return affected product and receive credit; complete and return the attached CUSTOMER REPLY FORM to Baxter via fax at 1-847-270-5457 or scan and email to fca@baxter.com and if you are a dealer, wholesaler or distributor/reseller, notify your customers of this recall. If you have questions regarding the communication, call 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 (nationwide) including: AL, LA, MO, SD, TX and WV; and country of: Canada.

Timeline

Recall initiated: 2011-07-06
Posted by FDA: 2011-07-15
Terminated: 2012-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102086. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.