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SUSI
Aesculap AG · Model BD239SU · UDI-DI 04046963892746
GEN
Prescription
10
510(k) clearances
673
Adverse events (3 deaths)
10
Recalls
452
Facilities
Description
CUSHING SUSI Dressing Forceps (Tweezers), 8", (200 mm), serrated, sterile, disposable, pack of 20 pcs, single packed
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-11-12 | MEDLINE INDUSTRIES, LP - Northfield | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-11-12 | MEDLINE INDUSTRIES, LP - Northfield | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2018-09-20 | Micro-Tech (Nanjing) Co., Ltd. | Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units |
| 2016-10-28 | Integra York PA, Inc | The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2010-06-25 | Biomet Microfixation, Inc. | The forceps insulation may have cracks or breaks in the insulation that may cause burns to patients when used. |
| 2003-08-29 | Cordis Corporation | Some devices may have an incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length |
| 2003-08-29 | Cordis Corporation | Some devices may have an incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length |
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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.