Medtronic Perfusion Systems: Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.

Is my product affected?

Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.

• UPC 00643169981102

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

What happened

Medtronic recalled 27 tubing packs of its HY7M07R6 Custom Perfusion System because specific lots may have been manufactured with insufficient or incomplete welds. The affected product was distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. Three lot numbers are involved: 220866430 (Use By 2022-04-03), 221102361 (Use By 2202-04-03), and 221727287 (Use By 2022-09-29).

The source does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Specific lots may have been manufactured with insufficient or incomplete welds.

Details from the source

Reason for recall: Specific lots may have been manufactured with insufficient or incomplete welds. Distribution: US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution. Quantity: 27 tubing packs Lot/code info: GTIN 00643169981102, Lot numbers 220866430, Use By 2022-04-03; 221102361, Use By 2202-04-03; and 221727287, Use By 2022-09-29.

Source

Official record: FDA (Device enforcement) ↗

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

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