Reported Nov 5, 2014 · Terminated
Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that…
Cook Medical Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Medical Incorporated · 400 N Daniels Way · Bloomington, IN · 47404-9155
Is this the product you have?
- 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.
- Lot codes and dates
23 of 23 products
Products covered by this recall # Product as published 1 Model Numbers: SS-08-06 2 SS-08-10 3 SS-08-15 4 SS-10-06 5 SS-10-10 6 SS-10-15 7 SS-14-06 8 SS-14-10 9 SS-14-15. Lot numbers: P030214C 10 P020413A 11 P190813B 12 P020413B 13 P030214A 14 P020413F 15 P300913A 16 P020413D 17 P190813D 18 P030214B 19 P020413E 20 P190813F - Amount recalled
- 1239 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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