Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that con

FDA device recall Z-0124-2015 · posted 2014-10-24 · Terminated

Recall details

Recalling firm

Cook Medical Incorporated

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.

Action taken

On 9/26/2014, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected distributors and institutions Risk Managers/Recall Administration with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call Customer Relations at 1-800-457-4500 or 1-812-339-2235.

Root cause

Package design/selection

Status

Terminated

Product code

KNW

Quantity affected

1239 units

Distribution

Worldwide Distribution-USA (nationwide) including the states of Arizona, California, Colorado, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Pennsylvania, Texas, Vir

Date initiated

2014-09-26

Date posted

2014-10-24

Date terminated

2016-02-02

Location

Bloomington, IN

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