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ArcRoyal
GRI Medical & Electronic Technology Co., Ltd. · Model Model 10-519009 · UDI-DI 16931918135618
8
510(k) clearances
562
Adverse events
7
Recalls
123
Facilities
Description
Red Needle Counter_Foam-Mag_20Ct25-0401_Non-sterile_100 ea/cs
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2011-03-10 | Biomet, Inc. | The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution. |
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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.