Device Recall Endotek AlimaxxB Uncovered Biliary Stent

Lot Numbers: F727578A and IML4466A.

Gastroenterology-Urology Devices

2

Yes

Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI.

Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-204, 8 x 40, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. || Intended for palliation of malignant neoplasms in the biliary tree.

Lot Numbers: F727579A and IML4457A.

Gastroenterology-Urology Devices

2

Yes

Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI.

Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. || Intended for palliation of malignant neoplasms in the biliary tree.

Lot Numbers: F727581A, IML4481A and IML4482A.

Gastroenterology-Urology Devices

2

Yes

Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI.

Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-208, 10 x 40, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. || Intended for palliation of malignant neoplasms in the biliary tree.

Lot Numbers: F727582A, IML 4476A, IML4480A, IML4531A, IML 4573A and IML 4593A.

Gastroenterology-Urology Devices

2

Yes

Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI.

Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. || Intended for palliation of malignant neoplasms in the biliary tree.

Lot Numbers: F727583A, IML4453A, IML4487A, IML4488A and IML4533A.

Gastroenterology-Urology Devices

2

Yes

Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI.

Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. || Intended for palliation of malignant neoplasms in the biliary tree.