Z-1270-2013 Class II Terminated
FDA device recall Z-1270-2013 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) Code 2N8220: 5,950; B) Code 2N8221: 6,150; C) Code 2N8222: 1,850; D) Code 2N8223: 7,900; E) Code 6N8220: 52,200; F)…
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) Code 2N8220: 5,950; B) Code 2N8221: 6,150; C) Code 2N8222: 1,850; D) Code 2N8223: 7,900; E) Code 6N8220: 52,200; F) Code 6N8222: 1,200
Product Description
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.1", Vol. 0.85 mL, Injection Site Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; C) Product Code 2N8222: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2", Vol. 0.57 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; D) Product Code 2N8223: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 0.40 mL, Injection Site Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; E) Product Code 6N8220: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.6", Vol. 1.0 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; F) Product Code 6N8222: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2", Vol. 0.5 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets 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 2N8220: Lots R12J05070; B) Product Code 2N8221: Lots R12J20046, R12J22042; C) Product Code 2N8222: Lots R12L07031; D) Product Code 2N8223: Lots R12L06074, R12K02083; E) Product Code 6N8220: Lots R12I01054, R12H25048, R12H27192, R12J04057, R12J22109, R12L07049, R12L08088; F) Product Code 6N8222: Lots R12J15046, R12J23115
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1270-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026