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FDA (Device enforcement)Recalled 2022-02-25class ii

Stradis Medical, LLC dba Stradis Healthcare: Surgicare Neuro Pack - Neurological Kit

Is my product affected?

Surgicare Neuro Pack - Neurological Kit

  • UPC 20143461101
  • UPC 20156461682
  • UPC 20217462972
  • UPC 20309467143
  • UPC 20343467142
  • UPC 20364467508
  • UPC 20364468264
  • UPC 21076471300
  • UPC 21082471463
  • UPC 21102472013
  • UPC 21117472929
  • UPC 21126473545

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

What happened

Stradis Medical, LLC dba Stradis Healthcare has recalled 176 units of the Surgicare Neuro Pack - Neurological Kit due to a hazard where the outer bag may be perforated or torn, potentially compromising the sterility of the kit. The affected product was distributed nationwide in Indiana, Texas, and Pennsylvania under SKU/Part Number 570-2224 and UDI H65257022240, with the recall involving multiple lot numbers ranging from 20143461101 through 21126473545.

The source document does not specify a remedy or corrective action for consumers who may have this product.

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

Hazard

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

Details from the source

Reason for recall: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of IN, TX, and PA. Quantity: 176 units Lot/code info: SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545

Source

Official record: FDA (Device enforcement) ↗

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

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