Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome recall
Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and…
Why was Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Cook Medical Incorporated
- Quantity
- 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, 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.
- Recall date
- November 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)