Recall Z-0124-2015— Cook Medical Incorporated

Name: FDA recall Z-0124-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-26

Class II · Terminated

Class II FDA medical device recall by Cook Medical Incorporated, initiated 2014-09-26, terminated 2016-02-02. It names 2 FDA 510(k) clearances: K080095, K060384. Product: 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: 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..

Recalling firm: Cook Medical Incorporated
Classification: Class II
Status: Terminated
Initiated: 2014-09-26
Terminated: 2016-02-02
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K080095 — CORAMATE/SPIROTOME SYSTEMMedinvents·cleared 2008-04-11
K060384 — CORAMATE/SPIROTOME SYSTEMMedinvents·cleared 2006-07-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.