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Terminated

King LTS-D Kit Size 1, Model Number KLTSD431

FDA Recall Z-1681-2019 · Posted None

Recalling FirmKing Systems Corp. dba Ambu, Inc.
Recall StatusTerminated
Product CodeCAE
Date Initiated2019-01-04
Date Terminated2020-04-20
Product Quantity270

Reason for Recall

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

Firm Action

Urgent Medical Device Recall notification letters were sent to customers beginning 1/4/19.

Root Cause

Packaging process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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