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Recall Observatory FDA recall evidence

Device product

King LTS-D Kit Size 1, Model Number KLTSD431

Z-1681-2019

January 04, 2019

Class II

Product summary

Firm
King Systems Corp. dba Ambu, Inc.
Event
Event 82036
Status
Terminated
Classification
Class II
Quantity
270
Official record key
device-enforcement:Z-1681-2019

Official wording

Reason: Size 0 products were incorrectly packaged and labeled as a size 1 products.

Code information: Lot code 1000147351

Distribution pattern: The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Size 0 products were incorrectly packaged and labeled as a size 1 products.