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MeroGel Otologic Packing 1x5cm

Anika Therapeutics, Inc. · Model 651-142 · UDI-DI 08033549790776

KHJ
10
510(k) clearances
23
Adverse events
2
Recalls
25
Facilities

Description

MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding and act as an adjunct to aid in the natural healing process.

Recalls

DateFirmReason
2024-11-22Cook Biotech, Inc.Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
2015-10-26Merz 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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Data 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.