PI CARDIA LTD: Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US

Is my product affected?

Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US

• UPC 7290020101242

Check against the official notice below — it lists the full affected range.

Hazard

Transfemoral catheter, positing arm may detached due to weld issue.

Details from the source

Reason for recall: Transfemoral catheter, positing arm may detached due to weld issue. Distribution: US Nationwide distribution in the states of Utah, Kansas, California, Massachusetts, Pennsylvania, New Hampshire, Delaware, and New York. Quantity: 46 units Lot/code info: UDI-DI - (01)7290020101242 All serial numbers in the affected lot SCUS-00013: SC919, SC920, SC921, SC923, SC924, SC925, SC926, SC927, SC928, SC929, SC930, SC931, SC932, SC933, SC934, SC935, SC936, SC937, SC938, SC939, SC940, SC941, SC942, SC943, SC944, SC945, SC946, SC947, SC948, SC949, SC950, SC951, SC952, SC953, SC954, SC956, SC957, SC958, SC960, SC961, SC962, SC963, SC964, SC966, SC967 and SC968.

Source

Official record: FDA (Device enforcement) ↗

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

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