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ENNOVATE
Aesculap AG · Model SZ364SU · UDI-DI 08033860029050
GAA
Prescription
10
510(k) clearances
1,796
Adverse events (1 deaths)
36
Recalls
322
Facilities
Description
ENNOVATE Aspiration Needle short, (150 mm), (120 mm), diam. 3,50 mm, trocar tip, plastic handles, stainless steel, sterile, disposable, 1 piece
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.