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GYRUS ACMI, INC
Gyrus ACMI, LLC · Model 143002 · UDI-DI 00821925019171
KHJ
Prescription
1
510(k) clearances
23
Adverse events
2
Recalls
25
Facilities
Description
VOCOM VOCAL CORD MDLZ 5MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-22 | Cook Biotech, Inc. | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
| 2015-10-26 | Merz North America, Inc. | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. |
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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.