Home / Recalls / Baxter Healthcare Corp. / Z-2687-2016

Z-2687-2016 Class II Terminated

Recalled by Baxter Healthcare Corp. — Round Lake, IL

FDA device recall Z-2687-2016 was initiated by Baxter Healthcare Corp. on Dec 14, 2012 and is designated Class II. Reason for recall: Some of the individual extension set packages were improperly sealed, compromising the sterility of the product. The recall status is terminated (terminated Dec 23, 2016). Affected quantity: 15,257 units.

Recall Details

Product Type: Devices
Report Date: Sep 7, 2016
Initiation Date: Dec 14, 2012
Termination Date: Dec 23, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15,257 units

Product Description

Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

Reason for Recall

Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.

Distribution Pattern

Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally to Canada.

Code Information

product code 2N3345, lot number UR12E03108

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2687-2016
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.

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)