FDA Device recall Z-0124-2015
Spirotome" Soft-Tissue Biopsy Needle Set
- FDA Device
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of Spirotome" Soft-Tissue Biopsy Needle Set by Cook Medical, citing 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 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0124-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-26 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cook Medical |
| Distribution | US |
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.
Identifiers
| code_info | 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 num…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0124-2015%22
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