Cook Medical Incorporated: Medical Device Recall in 2014 - (Recall #: Z-0124-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 26, 2014

Date Posted: November 5, 2014

Recall Number: Z-0124-2015

Event ID: 69417

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.

Status: Terminated

Product Quantity: 1239 units

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated