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umbili-CUTTER
Divergent Medical Technologies LLc · Model A01 · UDI-DI 00852568002176
7
510(k) clearances
11
Adverse events
3
Recalls
168
Facilities
Description
Clamp Cutter - Disposable umbilical cord clamp cutter, sterile, Tyvek pouch, Yellow, SUD. Box of 50 cutters
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-30 | MEDLINE INDUSTRIES, LP - Northfield | There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2023-08-03 | MEDLINE INDUSTRIES, LP - Northfield | 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile |
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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.