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Recall Observatory FDA recall evidence

Device product

Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19

Z-2492-2020

May 27, 2020

Class II

Product summary

Firm
Prodimed Plastimed Division
Event
Event 85776
Status
Terminated
Classification
Class II
Quantity
2580
Official record key
device-enforcement:Z-2492-2020

Official wording

Reason: Lack of assurance of sterility

Code information: All lots within expiry

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility