Home / Recalls / Cook Medical Incorporated / Z-0124-2015

Z-0124-2015 Class II Terminated

Recalled by Cook Medical Incorporated — Bloomington, IN

FDA device recall Z-0124-2015 was initiated by Cook Medical Incorporated on Sep 26, 2014 and is designated Class II. Reason for recall: MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due… The recall status is terminated (terminated Feb 2, 2016). Affected quantity: 1239 units.

Recall Details

Product Type: Devices
Report Date: Nov 5, 2014
Initiation Date: Sep 26, 2014
Termination Date: Feb 2, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1239 units

Product Description

Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.

Reason for Recall

MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. Further investigation disclosed potential dislodging of protective caps on the needle tips on other distributed products.

Distribution Pattern

Worldwide Distribution-USA (nationwide) including the states of Arizona, California, Colorado, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Pennsylvania, Texas, Virginia, Vermont, and Wisconsin, and the countries of AT; BE; CH; CY; CZ; DE; DK; ES; FI; FR; GB; HU; IC; IE; IS; IT; LB; LT; LU; NL; NO; PT; QA; SE; TR; and ZA.

Code Information

Model Numbers: SS-08-06; SS-08-10; SS-08-15; SS-10-06; SS-10-10; SS-10-15; SS-14-06; SS-14-10; SS-14-15. Lot numbers: P030214C; P020413A; P190813B; P020413B; P030214A; P020413F; P300913A; P020413D; P190813D; P030214B; P020413E; P190813F; P300913B; P020413C; P190813E.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0124-2015
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

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

Other recalls by Cook Medical Incorporated

Z-0043-2026 Class I — Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference… (Sep 18, 2025)
Z-1833-2024 Class II — EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 (Apr 1, 2024)
Z-1832-2024 Class II — EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 (Apr 1, 2024)
Z-0876-2022 Class III — Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN… (Feb 14, 2022)
Z-0875-2022 Class III — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog… (Feb 14, 2022)
Z-1024-2019 Class III — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog… (Feb 25, 2019)
Z-1022-2019 Class III — Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number… (Feb 25, 2019)
Z-1025-2019 Class III — Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog… (Feb 25, 2019)
Z-1021-2019 Class III — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number… (Feb 25, 2019)
Z-1026-2019 Class III — Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein… (Feb 25, 2019)