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PRIMO
Asp Global, LLC · Model PBIISW · UDI-DI 00840216112780
10
510(k) clearances
232
Adverse events (7 deaths)
4
Recalls
381
Facilities
Description
PRIMOBOOT II W/WEDGE, SMALL, 1SET/BG, 8BG/CS
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-06-09 | EHOB, Inc. | QC inspection observed that a portion of the lot may have been contaminated with blood. |
| 2015-12-01 | 3M Company - Health Care Business | Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex |
| 2014-10-10 | Philips Medical Systems, Inc. | Mold on gel filled Gel-E and Squishon products |
| 2014-05-28 | Childrens Medical Ventures | The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fu |
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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.