Bolton Medical Inc.: The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Gra

Hazard

Potential for the incorrect size stent-graft than the printed carton label.

Details from the source

Reason for recall: Potential for the incorrect size stent-graft than the printed carton label. Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland. Quantity: 216 units Lot/code info: a. GTIN Number: 00843576151963, Catalog Number (Lot Number): 28-S2-13-080U (2104270154); b. GTIN Number: 00843576151994, Catalog Number (Lot Number): 28-L2-13-080U (2104260081, 2104260083, 2104260082, 2104260085, 2104260084, 2104260087); c. GTIN Number: 00843576152007, Catalog Number: 28-L2-15-080U, Lot Number: 2104120114; d. GTIN Number: 00843576152038, Catalog Number (Lot Number): 28-L2-24-080U (2104230422, 2104230421); e. GTIN Number: 00843576152076, Catalog Number (Lot Number): 28-L2-15-100U (2104170055, 2104170053); f. GTIN Number: 00843576152083, Catalog Number (Lot Number): 28-L2-17-100U (2104230448, 2104230449, 2104230444, 2104230459, 2104230450, 2104230447, 2104230446, 2104230445, 2104230443, 2104230442, 2104230441, 2104230437, 2104230435); g. GTIN Number: 00843576152090, Catalog Number (Lot Number): 28-L2-20-100U (2104230399, 2104230394, 2104230391, 2104230392, 2104230395, 2104230401, 2104230398, 2104230403, 2104230406, 2104230404, 2104230409, 2104230408, 2104230412, 2104230411, 2104230400, 2104230396, 2104230390, 2104230405, 2104230402, 2104230407); h. GTIN Number: 00843576152137, Catalog Number (Lot Number): 28-L2-13-120U (2104230470, 2104230469, 2104230468, 2104230472, 2104230471); i; GTIN Number: 00843576152144, Catalog Number (Lot Number): 28-L2-15-120U (2104230365, 2104230371, 2104230370, 2104230366, 2104230364, 2104230363, 2104230372, 2104230369, 2104230368, 2104230367); j. GTIN Number: 00843576152229, Catalog Number (Lot Number): 28-L2-17-140U (2104270162, 2

UPC codes

00843576151963, 00843576151994, 00843576152007, 00843576152038, 00843576152076, 00843576152083, 00843576152090, 00843576152137, 00843576152144, 00843576152229, 00843576152342, 00843576152359, 00843576152366, 00843576152373, 00843576152441, 00843576152458, 00843576152472, 00843576152595, 00843576152601, 00843576152618, 00843576152656, 00843576152663, 00843576152670, 00843576152762, 08436045396747, 08436045396938, 08436045396976, 08436045396983, 08436045396990, 08436045397041, 08436045397126, 08436045397133, 08436045397195, 08436045397201, 08436045397249, 08436045397263, 08436045397287, 08436045397294, 08436045397430, 08436045397447

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.