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Recall Observatory FDA recall evidence

Device product

ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China

Z-0696-2016

January 06, 2016

Class II

Product summary

Firm
Global Healthcare Inc
Event
Event 73046
Status
Terminated
Classification
Class II
Quantity
2,000 cases (100 individual units per case)
Official record key
device-enforcement:Z-0696-2016

Official wording

Reason: Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.

Code information: Lot Number 1505201

Distribution pattern: US Distribution to state of: GA only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.