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Recall Observatory FDA recall evidence

Device product

MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.

Z-2683-2016

December 03, 2015

Class II

Product summary

Firm
Teleflex Medical
Event
Event 74793
Status
Terminated
Classification
Class II
Quantity
2,700 units
Official record key
device-enforcement:Z-2683-2016

Official wording

Reason: Cracking may occur at the 15mm and 22mm ISO female connector.

Code information: Model number: 01-06-8125-8, Product code: XKC01-06-8125-8, Lot numbers: 201450, 201451, 201452 and 201504.

Distribution pattern: US Distribution to the states of : FL, KS, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cracking may occur at the 15mm and 22mm ISO female connector.