Reported Nov 28, 2012 · Terminated
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible…
King Systems Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: King Systems Corp. · 15011 Herriman Blvd · Noblesville, IN · 46060
Is this the product you have?
- KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿
- Patient Size10-20kg
- Product UsageLaryngeal airway
- Lot codes and dates
- REF
LAD-902Lot #K120414
- REF
- Amount recalled
- 263 cases of product. (2,630 devices)
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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