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Recall Observatory FDA recall evidence

Device product

Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US

Z-2491-2020

May 27, 2020

Class II

Product summary

Firm
Prodimed Plastimed Division
Event
Event 85776
Status
Terminated
Classification
Class II
Quantity
180
Official record key
device-enforcement:Z-2491-2020

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