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Medline
MEDLINE INDUSTRIES, INC. · Model HCSS4516SF · UDI-DI 10193489006377
10
510(k) clearances
1,798
Adverse events (30 deaths)
6
Recalls
264
Facilities
Description
CANNULA,OXY,ADL,SSOFT,W/14'TUB,SC, FOAM
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.