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Cannula Kit
SUNSET HEALTHCARE SOLUTIONS, INC. · Model RES02KITAO · UDI-DI 00848530094799
10
510(k) clearances
1,812
Adverse events (30 deaths)
6
Recalls
267
Facilities
Description
(1) RES001, (3) RES1107, (2) RES1125, (1) RES050, (1) RES003
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-06 | Smiths Medical ASD Inc. | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| 2018-07-06 | Smiths Medical ASD Inc. | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| 2018-07-06 | Smiths Medical ASD Inc. | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| 2018-07-06 | Smiths Medical ASD Inc. | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| 2018-07-06 | Smiths Medical ASD Inc. | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| 2017-05-09 | Teleflex Medical | Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device. |
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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.