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Silon-TSR Face Mask Kit

Bio Med Sciences, Inc. · Model 2200P-K · UDI-DI 00810050460057

MGP
1
510(k) clearances
95
Adverse events (1 deaths)
1
Recalls
22
Facilities

Description

Perforated Temporary Skin Replacement Face Mask, Spandage® Tubular Net Dressing, Mastisol® Liquid Adhesion Promoter and5 pks. (2) Sterile 4” x 4” Absorbent Gauze Pads

Recalls

DateFirmReason
2011-02-11Hartmann USA, IncMisbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. Consignees were notified by letter on/about 02/11/2011. They were advised to e

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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.