Home / Recalls / Baxter Healthcare Corp. / Z-0143-2014

Z-0143-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0143-2014 was initiated by Baxter Healthcare Corp. on Sep 10, 2013 and is designated Class II. Reason for recall: The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events. The recall status is terminated (terminated Jun 5, 2015). Affected quantity: 628,992 units.

Recall Details

Product Type: Devices
Report Date: Nov 13, 2013
Initiation Date: Sep 10, 2013
Termination Date: Jun 5, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 628,992 units

Product Description

Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.

Reason for Recall

The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the country of Canada.

Code Information

10043, 10044

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0143-2014
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.

Other recalls by Baxter Healthcare Corp.

Z-3133-2017 Class II — Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 (Sep 1, 2017)
Z-0370-2017 Class II — GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code… (Oct 12, 2016)
Z-0672-2017 Class II — V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA… (Sep 28, 2016)
Z-0671-2017 Class II — Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum… (Sep 28, 2016)
Z-0670-2017 Class II — sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum… (Sep 28, 2016)
Z-2533-2016 Class II — Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product… (Jun 24, 2016)
Z-2049-2016 Class II — PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy (May 23, 2016)
Z-1838-2016 Class II — COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular… (May 12, 2016)
Z-1840-2016 Class II — COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular… (May 12, 2016)
Z-1839-2016 Class II — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular… (May 12, 2016)