A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension… recallZ-1269-2013 · Baxter Healthcare Corp. · initiated Mar 28, 2013
Class II Terminated All recalls posted in May 2013
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
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
FDA root cause category: Packaging process control
What the company is doing
Baxter sent an "Urgent Product Notification" dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taked. Customers are advised to locate and remove all of the affected products from their inventory. If the products were further distributed, consigneees are requested to notify their customers of the recall. Products can be returned for credit by contacting Baxter. An acknowledgement form is required to be compelted by customers.
Recall details
- Recall number
- Z-1269-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 28, 2013
- Posted by the FDA
- May 7, 2013
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- A) Product Code 2N3371: 228,200 units
- Product code
- FPA
- FDA submissions
- K925126
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Product description
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.
Code information (models, lots, serial numbers)
A) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057
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
Other products in the same recall event
The FDA groups related products into one recall event (event 64696).
- Z-1271-2013 · TerminatedA) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV exte…
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.
How recalls are matched to devices · Editorial policy · Report an error on this page