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Z-1271-2013 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-1271-2013 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 2N8371: 513,000 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 2N8371: 513,000 units

Product Description

A) 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 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 2N8371: Lots R12E03108, R12H27085, R12H28075, R12H29057, R12H30139, R12103092, R12104058, R12105022, R12106061, R12110113, R12119056, R12120112, R12121151, R12122050, R12124106, R12124130, R12J25045, R12K03057, R12K19046, R12K21034, R12K21083, R12L05118, R12L08054, R12L18111, R12Ll9101, R13A08063, R13A08147, Rl3A09137, R13A10101, R13A14129, R13A15050

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1271-2013
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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