BIOGLUE SURGICAL ADHESIVE

Model: CRY-BG3515-5, Affected: Lot No: all lot numbers pre 14MGV024

Medical Device Safety Alert: CryoLife BioGlue Surgical Adhesive 5mL

12MUV034, 12MUX035, 12MUV069, 12MUV037, 12MUV038, 12MUV040, 12MUV041, 12MUV042, 12MUV043, 12MUV044, 12MUV045, 12MUV046, 12MUV047, 12MUV048, 12MUV049, 12MUV050, 12MUV051, 12MUV052, 12MUV053, 12MUV054, 12MUV055, 12MUV056, 12MUV057, 12MUV058, 12MUV059, 12MUV060, 12MUV061, 12MUV062, 12MUV063, 12MUV064, 12MUV065, 12MUV067, 12MUV068, 12MUV069, 12MUV070, 12MUV071, 12MUV072, 12MUV073, 12MUV074, 12MUV075, 12MUV076, 13MUV001, 13MUV002, 13MUV003, 13MUV004,

Cardiovascular Devices

3

Yes

Distributed Nationwide including Puerto Rico and the states of AL, AK,AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM , NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI.

BG3515-5 US 5mL BioGlue Surgical Adhesive. || BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries).

Model Catalog: BG3010-5-G-RT (Lot serial: ALL LOTS); Model Catalog: BGAT-RT (Lot serial: ALL LOTS); Model Catalog: BG3010-5-G-RT (Lot serial: 7RT002); Model Catalog: BGAT-RT (Lot serial: 7RT002); Model Catalog: BG3010-5-G-RT (Lot serial: 7RT001); Model Catalog: BGAT-RT (Lot serial: 7RT001)

BIOGLUE RIGID APPLICATOR TIPS