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BIOPSYBELL SRL
BIOPSYBELL SRL · Model STERNOBELL EXPLANT · UDI-DI 08033860042905
1
510(k) clearances
4,892
Adverse events (27 deaths)
54
Recalls
129
Facilities
Description
NEEDLE FOR BONE MARROW EXPLANT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-02 | Bard Peripheral Vascular Inc | Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised. |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2024-04-01 | Cook Medical Incorporated | Devices may contain elevated levels of bacterial endotoxin. |
| 2024-04-01 | Cook Medical Incorporated | Devices may contain elevated levels of bacterial endotoxin. |
| 2023-03-31 | Olympus Corporation of the Americas | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during need |
| 2023-03-31 | Olympus Corporation of the Americas | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during need |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 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.