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FDA Medical Device Recall Series - July 2019

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Total 2019 Recalls as of July

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July 2019 Recalls

July 2019 FDA Recall List

Models Affected:

  • ICF100
    UDI code (01) 00690103190007

Lots:

  • 60972890
  • 61078031
  • 61097633
  • 61139239
  • 61259627
  • 61259628
  • 61713218
  • 61723505
  • 61898939

 

Recall Details

Models Affected:

  • Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001)

Lots:

  • All serial numbers below 16192 with software versions ≤ 2.60

 

Recall Details

Models Affected:

  • 2063568-001-XXXXXX
  • 2063570-001-XXXXXX
  • M1112198-XXXXXX
  • M1118179-XXXXXX

Lots:

  • All lots are involved

 

Recall Details

Models Affected:

  • Product Codes: 870-07KIT, 870-09KIT

Lots:

  • 74L1802044
  • 74L1802045

 

Recall Details

Models Affected:

  • Model 8100

Lots:

  • Manufacturing Dates: April 2011 to June 2017*

* This product was initially recalled on August 9, 2017 (FDA Recall # Z-0026-2018).  The firm subsequently expanded the recall on April 13, 2018 to expand the volume of product impacted.  On February 1, 2019, BD further expanded the recall to include all Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017.

 

Recall Details

If your organization needs help coordinating logistics, etc. related to any of the above Recalls, please don’t hesitate to contact us.

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