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FDA (Device enforcement)Recalled 2019-02-08closedclass ii

Riverpoint Medical, LLC: Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.

Is my product affected?

Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.

  • UPC 00812444028638

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

What happened

Riverpoint Medical, LLC is recalling 3,234 Riverpoint Medical 18G Brachy Grid devices (B&K style, REF RPG-18, Sterile, Rx) because the integrity of the sterile grid packaging is potentially compromised. The affected devices were distributed to Illinois, Florida, Texas, and Washington and are identified by lot numbers 16032422, 16051814, 16051815, 16052425, 17042430, 17050936, 17052532, 17061214, 17121823, 17122820, 18040922, 18061816, 18101521, and 18120705, or UDI number 00812444028638.

The source document does not specify a remedy or action that affected consumers should take.

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

Hazard

The integrity of the sterile grid packaging is potentially compromised.

Details from the source

Reason for recall: The integrity of the sterile grid packaging is potentially compromised. Distribution: Distribution was made to IL, FL, TX, and WA. There was no foreign/military/government distribution. Quantity: 3,234 devices Lot/code info: Lot numbers 16032422, 16051814, 16051815, 16052425, 17042430, 17050936, 17052532, 17061214, 17121823, 17122820, 18040922, 18061816, 18101521, and 18120705; UDI number 00812444028638.

Source

Official record: FDA (Device enforcement) ↗

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

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