Recall Z-0425-2013— King Systems Corp.
Class II · Terminated
Class II FDA medical device recall by King Systems Corp., initiated 2012-11-02, terminated 2013-05-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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.
- Recalling firm
- King Systems Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-02
- Terminated
- 2013-05-28
- Firm location
- Noblesville, IN, United States
Product description
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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.