CLASS II Device recall · Reported 5 Jun 2019 · FDA Enforcement Report
King Lts-d Kit Size recalled by King Systems
King Systems is recalling King Lts-d Kit Size 1, distributed in 11 states. The recall was initiated on 4 Jan 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1681-2019
- FDA event ID
- 82036
- Recalling firm
- King Systems, Noblesville, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jan 2019
- FDA classified
- 29 May 2019
- Reported
- 5 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 4 Jan 2019 | Recall initiated by company | |
| 29 May 2019 | Classified by FDA | +145 days |
| 5 Jun 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Size 0 products were incorrectly packaged and labeled as a size 1 products.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
King LTS-D Kit Size 1, Model Number KLTSD431
Where it was distributed
The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.
CaliforniaConnecticutFloridaIowaIndianaMarylandMississippiNorth CarolinaPennsylvaniaTexasWisconsin
Questions about this recall
Why was it recalled?
Size 0 products were incorrectly packaged and labeled as a size 1 products.
Which lots are affected?
Lot code 1000147351
Where was it sold?
The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | King Ltsd,Size 2,W/Suction Port Sterile-Inserted into recalled | King Systems | Other | Nationwide |
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