Z-1681-2019Class II

King LTS-D Kit Size 1, Model Number KLTSD431

Name: Z-1681-2019 King LTS-D Kit Size 1, Model Number KLTSD431
Creator: King Systems Corp. dba Ambu, Inc.
Published: 2019-01-04
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2019-01-04 / Terminated / root cause: packaging

FDA source

King Systems Corp. dba Ambu, Inc. began a recall of King LTS-D Kit Size 1, Model Number KLTSD431 on 2019-01-04. FDA classified it as Class II and gives the reason as "Size 0 products were incorrectly packaged and labeled as a size 1 products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1681-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Posted: 2019-05-29
Terminated: 2020-04-20
Recalling firm: King Systems Corporation.
Product: King LTS-D Kit Size 1, Model Number KLTSD431
Product code: CAE Airway, Oropharyngeal, Anesthesiology
Reason for recall: Size 0 products were incorrectly packaged and labeled as a size 1 products.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Urgent Medical Device Recall notification letters were sent to customers beginning 1/4/19.
Quantity in commerce: 270
Distribution: The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.
Product codes and lots: Lot code 1000147351

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1681-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1681-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-29

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)