Z-1269-2013 Class II Terminated
FDA device recall Z-1269-2013 was initiated by Baxter Healthcare Corp. on Mar 28, 2013 and is designated Class II. Reason for recall: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. The recall status is terminated (terminated Jul 31, 2017). Affected quantity: A) Product Code 2N3371: 228,200 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2013
- Initiation Date
- Mar 28, 2013
- Termination Date
- Jul 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- A) Product Code 2N3371: 228,200 units
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.
Reason for Recall
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Code Information
A) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1269-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026