KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD Patient Size: 1

FDA device recall Z-0418-2013 · posted 2012-11-21 · Terminated

Recall details

Recalling firm

King Systems Corp.

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

Action taken

King Systems sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated October 31, 2012 to all affected consignees via email. The letter identified affected product, problem and actions to be taken. The letter states that further use and/or distribution of any remaining product affected by this recall should cease immediately. The letter instructs customers to destroy all of the affected products and indicate the destruction by signing and returning the attached forms using the enclosed self-addressed envelope. For questions contact your King Systems customer service representative at 800-642-5464.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CAE

Quantity affected

263 cases of product. (2,630 devices)

Distribution

US Nationwide Distribution - WI, TX, NY, MO, IN, KY, FL, NJ, PA, TN, and NC

Date initiated

2012-11-02

Date posted

2012-11-21

Date terminated

2013-05-28

Location

Noblesville, IN