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SAFE DENT
BGSS Company Inc. · Model PC4018GRY · UDI-DI 00854014003539
10
510(k) clearances
263
Adverse events (3 deaths)
17
Recalls
275
Facilities
Description
PC4018GRY GREY 5oz plastic dental cups
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-04 | Avanos Medical, Inc. | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. |
| 2024-03-04 | Avanos Medical, Inc. | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. |
| 2024-03-04 | Avanos Medical, Inc. | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. |
| 2023-03-20 | Baxter Healthcare Corporation | ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 | Baxter Healthcare Corporation | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
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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.