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SOURCE SURGICAL INC.
KENPAX INTERNATIONAL LIMITED · Model 1 · UDI-DI 74895237141467
10
510(k) clearances
128
Adverse events
9
Recalls
801
Facilities
Description
Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-18 | MEDLINE INDUSTRIES, LP - Northfield | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2021-01-07 | Cardinal Health 200, LLC | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2021-01-07 | Cardinal Health 200, LLC | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2021-01-07 | Cardinal Health 200, LLC | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2021-01-07 | Cardinal Health 200, LLC | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2021-01-07 | Cardinal Health 200, LLC | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2021-01-07 | Cardinal Health 200, LLC | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| 2017-09-11 | Zimmer Biomet, Inc. | Cut resistant surgical glove liners lack sterility assurance. |
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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.