Baxter Interlink System Non-DEHP Y-Type Catheter Extension… recallZ-1424-05 · Baxter Healthcare Corp. · initiated Aug 3, 2005
Terminated All recalls posted in August 2005
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
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
FDA root cause category: Other
What the company is doing
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
Recall details
- Recall number
- Z-1424-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 3, 2005
- Posted by the FDA
- Aug 30, 2005
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 24,200 sets
- Product code
- FPA
- FDA submissions
- K791496, K925126
- Distribution
- Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.
Product description
Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx sterile, nonpyrogenic fluid pathway, 5.7'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Code information (models, lots, serial numbers)
Product code 2N3371, lots UR247189, UR268656, UR268920, UR270256; extended to include lotsUR255919 and UR261560
Other devices under the same FDA submission
5 devices cleared under K791496, 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
- NA 2C1145Baxter International Inc. · 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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