Cook Medical Recalls Spirotome Soft-Tissue Biopsy Needle Sets
Cook Medical is voluntarily recalling Spirotome Soft-Tissue Biopsy Needle Sets because protective caps may have dislodged inside the packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary measure initiated due to potential packaging defects (dislodged caps) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Cook Medical Incorporated, the distributor of the Spirotome Soft-Tissue Biopsy Needle Set manufactured by MEDINVENTS, has initiated a voluntary recall of 1,239 units. The recall was initiated due to customer complaints that the protective caps were dislodged in the pouch. Further investigation disclosed the potential for dislodging of protective caps on the needle tips on other distributed products.
The Spirotome Biopsy Needle Set is intended for the percutaneous acquisition of soft tissue specimens for laboratory analysis. The affected products include 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, and SS-14-15. Specific lot numbers are listed in the agency's recall record.
The products were distributed worldwide, including nationwide in the United States and in various countries across Europe, the Middle East, and Africa. Healthcare facilities and consumers should stop using the affected products and contact Cook Medical for instructions on how to return them.
The recalled product
- 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…
- Manufacturer
- Cook Medical Incorporated
- Category
- Medical Device — Biopsy Needle
- Hazard
- Affected units
- 1,239
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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