Olympus Corporation of the Americas: To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the

Hazard

Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.

Details from the source

Reason for recall: Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction. Distribution: Natiowide Foreign: Canada, Germany Quantity: 1297 (Boxes; 5 per Box) Lot/code info: UDI: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937

UPC codes

04953170388286

Source

Official record: FDA (Device enforcement) ↗

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