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ACTABOND™ Topical Skin Adhesive

BERGEN MEDICAL PRODUCTS, INC. · Model ACT6 · UDI-DI 00008626160003

MPN Prescription
1
510(k) clearances
3,662
Adverse events (7 deaths)
2
Recalls
36
Facilities

Description

Tissue adhesive for the topical approximation of skin

Recalls

DateFirmReason
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2021-01-04Ethicon, Inc.Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

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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.