Biliary Catheters

Model: Model Numbers: A4403, A4405, A4406, A4407, A4752, A4F00, A4F01, A4F02, A4F03, A4F04, A4F05, A4F06, A4F07, A4F08., Affected: 48 lots

Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

Biliary Catheters (Models A47XX and CB0XXXXX): || Model Numbers & Description: || A4752, SYNTEL BILIARY 5F-23CM CATHETER; || A4754, SYNTEL BILIARY 5F-40CM CATHETER; || A4762, SYNTEL BILIARY 6F-23CM CATHETER; || CB052308, SYNTEL BILIARY 5F-23CM CATH; || CB054008, SYNTEL BILIARY 5F-40CM CATH; || CB062313, SYNTEL BILIARY 6F-23CM CATH. || Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.

Syntel Vascular Catheters and Syntel Biliary Catheters (embolectomy catheter)Syntel Vascular CathetersModel Numbers: A4403, A4405 to A4407 (inc), A4F00 to A4F08 (inc.)Lot Numbers: Multiple lots affectedARTG Number: 116754Syntel Biliary CathetersModel numbers: A4752Lot numbers: 1165670ARTG Number: 116815

Gastroenterology-Urology Devices