Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Reason for recall: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reu Quantity: 26 units Lot/code info: GTIN: 00763000178253, Serial Number: RTS605244S; GTIN: 00763000178277, Serial Numbers: RTS604876S, RTS604877S, RTS604879S, RTS604885S; GTIN: 00763000711245, Serial Numbers: RTS604695S, RTS604698S, RTS604700S, RTS604703S, RTS604704S, RTS604714S, RTS604716S, RTS604717S, RTS604718S, RTS604721S, RTS604722S, RTS604723S, RTS604724S, RTS604726S, RTS604727S, RTS604728S, RTS604729S, RTS604730S, RTS604731S, RTS604732S, RTS604733S.
00763000178253, 00763000178277, 00763000711245
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.