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Terminated

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.

FDA Recall Z-0124-2015 · Posted 2014-10-24

Recalling FirmCook Medical Incorporated
Recall StatusTerminated
Product CodeKNW
Date Initiated2014-09-26
Date Terminated2016-02-02
Product Quantity1239 units

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.

Firm Action

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

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080095CORAMATE/SPIROTOME SYSTEMMedinvents · 2008-04-11K060384CORAMATE/SPIROTOME SYSTEMMedinvents · 2006-07-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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