Z-1268-2013 Class II Terminated
FDA device recall Z-1268-2013 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 2N1191: 53,850; B) Product Code 2N1206: 101,900 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 2N1191: 53,850; B) Product Code 2N1206: 101,900 units
Product Description
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.
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 2N1191: Lots R12J06052, R12J08041, R12K06134, R12K08015, R12K26108, R12K27155; B) Product Code 2N1206: Lots R12J08124, R12J24121, R12K01119, R12K23089, R12K24053, R12K22016
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1268-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026