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US Accessory Kit
MERZ NORTH AMERICA, INC. · Model 8070M0 · UDI-DI 00810235030860
GAA
Prescription
10
510(k) clearances
1,806
Adverse events (1 deaths)
36
Recalls
323
Facilities
Description
One Needle, One female to female luer lock connector, and one, 3mL Syringe
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-29 | Hobbs 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 |
| 2022-07-29 | Hobbs 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 |
| 2021-08-27 | North American Rescue LLC. | The device includes the incorrect Instructions for Use. |
| 2021-08-05 | M.D.L. S.r.l. | Sterility assurance may be compromised. |
| 2021-04-21 | INNOVATIVE TOMOGRAPHY PRODUCT GMBH | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized |
| 2021-04-21 | INNOVATIVE TOMOGRAPHY PRODUCT GMBH | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized |
| 2021-04-21 | INNOVATIVE TOMOGRAPHY PRODUCT GMBH | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized |
| 2021-01-04 | Aomori 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. |
| 2021-01-04 | Aomori 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. |
| 2021-01-04 | Aomori 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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Get your free API keyRead the docsData 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.