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BV Medical · Model 20-342-244-Autism-L · UDI-DI 00845821029621
10
510(k) clearances
677
Adverse events (3 deaths)
10
Recalls
455
Facilities
Description
Autism Combo Kit: Red Carrying Case: 20-342-244-L Aneroid Sphygmomanometer, Latex Free PVC: 30-510-254-A GemScope,Autism Awareness, Adult, Royal Blue, Latex Free: 60-400-011 High Intensity Otoscope Penlight, Reusable, Black, Retail Pack: 80-500-999 Taylor Percussion Hammer, Stealth: 80-174-250 Kelly forceps, 5.5", straight, stainless steel with royal blue handle: 3D Pedometer
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.