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Halyard
OWENS & MINOR DISTRIBUTION, INC. · Model 48743 · UDI-DI 10885632373336
8
510(k) clearances
783
Adverse events (2 deaths)
7
Recalls
285
Facilities
Description
FOAM POSITIONER OR TABLE POSITIONING KITS TRENDELENBURG PAD POLYURETHANE FOAM BLUE INCLUDES EXTRA LARGE TRENDELENBURG PAD X1 CHEST PAD X1 BODY STRAP X1 HEAD POSITIONER X1 PAIR OF TRENDELENBURG ARM PROTECTORS X1 DISPOSABLE NOT MADE WITH NATURAL RUBBER LATEX HALYARD
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2021-07-23 | Aspen Surgical Products, Inc. | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the |
| 2021-07-23 | Aspen Surgical Products, Inc. | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the |
| 2021-07-23 | Aspen Surgical Products, Inc. | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the |
| 2014-05-08 | Covidien LLC | Straps may separate from the foam pad. |
| 2011-11-16 | Allen Medical Systems, Inc. | C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity |
| 2007-11-27 | Allen Medical Systems, Inc. | Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury. |
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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.