Baxter Interlink System Non-DEHP I.V. Catheter Extension… recallZ-2837-2011 · Baxter Healthcare Corp. · initiated Jul 6, 2011
Terminated All recalls posted in July 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
FDA root cause category: Packaging
What the company is doing
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 [email protected] 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.
Recall details
- Recall number
- Z-2837-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 6, 2011
- Posted by the FDA
- Jul 15, 2011
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 9,800 sets
- Product code
- FPA
- FDA submissions
- K925126
- Distribution
- Worldwide distribution: USA (nationwide) including: AL, LA, MO, SD, TX and WV; and country of: Canada.
Product description
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.
Code information (models, lots, serial numbers)
product code 2N3375, lot number UR09H05029, expiration date 8/25/2014.
Other devices under the same FDA submission
4 devices cleared under K925126 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INTERLINK 2N3374Baxter International Inc. · Set, administration, intravascular7 reports
- INTERLINK 2N3378Baxter International Inc. · Set, administration, intravascular7 reports
- INTERLINK 2N3379Baxter Healthcare Corporation · Set, administration, intravascular6 reports
- INTERLINK 2N3399Baxter Healthcare Corporation · Set, administration, intravascular2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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