Z-0132-2016 Class II Terminated

Recalled by Baxter Healthcare Corp — Deerfield, IL

FDA device recall Z-0132-2016 was initiated by Baxter Healthcare Corp on May 21, 2015 and is designated Class II. Reason for recall: Potential for a leak at the tubing to luer bond. The recall status is terminated (terminated May 10, 2017). Affected quantity: 23,600.

Recall Details

Product Type
Devices
Report Date
Oct 28, 2015
Initiation Date
May 21, 2015
Termination Date
May 10, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23,600

Product Description

ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT

Reason for Recall

Potential for a leak at the tubing to luer bond.

Distribution Pattern

Domestic Only

Code Information

Code: 7N8371, Lots: UR15B16021 and UR15B23043

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0132-2016
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.