During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Reason for recall: During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. Distribution: Worldwide - US Nationwide distribution. Quantity: 134 units Lot/code info: UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115
00643169668911
Official record: FDA (Device enforcement) ↗
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