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CytoCut

M.D.L. S.R.L. · Model PB2020 · UDI-DI 08056138584808

GAA Prescription
10
510(k) clearances
1,796
Adverse events (1 deaths)
36
Recalls
322
Facilities

Description

DISPOSABLE CHIBA NEEDLE 20G X 200 mm FOR ASPIRATED CYTO-HISTOLOGICAL BIOPSY

Recalls

DateFirmReason
2022-07-29Hobbs Medical, Inc.Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration
2022-07-29Hobbs Medical, Inc.Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration
2021-08-27North American Rescue LLC.The device includes the incorrect Instructions for Use.
2021-08-05M.D.L. S.r.l.Sterility assurance may be compromised.
2021-04-21INNOVATIVE TOMOGRAPHY PRODUCT GMBHSterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
2021-04-21INNOVATIVE TOMOGRAPHY PRODUCT GMBHSterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
2021-04-21INNOVATIVE TOMOGRAPHY PRODUCT GMBHSterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
2021-01-04Aomori Olympus Co., Ltd.Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
2021-01-04Aomori Olympus Co., Ltd.Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
2021-01-04Aomori Olympus Co., Ltd.Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.