CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report
King Lad Standard ClearSeal Single Use recalled by King Systems
King Systems is recalling King Lad Standard ClearSeal Single Use, King Systems Eto Sterilie, 20 devices/case Size 2, distributed nationwide in the US. The recall was initiated on 2 Nov 2012 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-0425-2013
- FDA event ID
- 63580
- Recalling firm
- King Systems, Noblesville, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Nov 2012
- FDA classified
- 21 Nov 2012
- Reported
- 28 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 2 Nov 2012 | Recall initiated by company | |
| 21 Nov 2012 | Classified by FDA | +19 days |
| 28 Nov 2012 | 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
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
Where it was distributed
US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
Nationwide FloridaIndianaKentuckyMissouriNorth CarolinaNew JerseyNew YorkPennsylvaniaTennesseeTexasWisconsin
Questions about this recall
Why was it recalled?
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
Which lots are affected?
REF: LAD-902, Lot #K120414
Where was it sold?
US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC
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.
Other products in this recall event
9 other products · FDA event 63580This product is part of a recall event; the main page for the event is King Lad Flexible ClearSeal Single Use recalled by King Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | King Lad Flexible ClearSeal Single Use recalled by King Systems | King Systems | Sterility | Nationwide | |
| CLASS II | King Lad Flexible ClearSeal Single Use recalled by King Systems | King Systems | Sterility | Nationwide | |
| CLASS II | King Lad Sili Cone Single Use, King Systems recalled | King Systems | Sterility | Nationwide | |
| CLASS II | King Lad Standard ClearSeal Single Use recalled by King Systems | King Systems | Sterility | Nationwide | |
| CLASS II | King Lad Standard ClearSeal Single Use recalled by King Systems | King Systems | Sterility | Nationwide | |
| CLASS II | King Lad Sili Cone Single Use, King Systems devices/case recalled | King Systems | Sterility | Nationwide | |
| CLASS II | King Lad Sili Cone Single Use, King Systems recalled | King Systems | Sterility | Nationwide | |
| CLASS II | King Lad Sili Cone Single Use, King Systems recalled | King Systems | Sterility | Nationwide | |
| CLASS II | King Lad Standard ClearSeal Single Use recalled by King Systems | King Systems | Sterility | Nationwide |
More recalls from King Systems
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | King Ltsd,Size 2,W/Suction Port Sterile-Inserted into recalled | King Systems | Other | Nationwide |
| Device | CLASS II | King Ltsd,Size 2.5, W/Suction Port Sterile-Inserted into recalled | King Systems | Other | Nationwide |
| Device | CLASS II | King Ltsd,Size 0, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Other | Nationwide |
| Device | CLASS II | King Ltsd,Size 2, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Other | Nationwide |
| Device | CLASS II | King Ltsd,Size 1, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Other | Nationwide |
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