—#97884

Product

Face Tent with 15 mm Adapter, REF S-MD126, Manufacturer: King Systems Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

FDA product code: BYG — Mask, Oxygen
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: IPCF2, IQ3Y0, IQ698, IQPU1, IQUZ0, IR2I7, IRFY3, ISEX6, ISJN6 and IT3Q0.

Why it was recalled

The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. The sticky substance could result in inconvenience or in some remote cases cause patient harm.

Root cause (FDA determination)

Other

Action the firm took

The firm issued an URGENT PRODUCT RECALL letter dated 1/24/2011. The letter identified the affected product and stated the reason for recall. The letter instructed consignees to cease all sales, to immediately examine their inventory, and to quarantine the product. The letter included a response form that is to be completed and returned. Distributors were instructed to inform their customers of the recall. King Systems Customer Service Department should be contacted at 1-800-642-5464 in order to receive a Return Authorization Number. The letter stated that consignees should return the recalled products to King Systems and the firm will replace the products or provide an acceptable substitute. Customers should contact Customer Service if they have any questions regarding the recall and the letter.

Recalling firm

Firm: King Systems Corp.
Address: 15011 Herriman Blvd, Noblesville, Indiana 46060

Distribution

Distribution pattern: Nationwide Distribution -- NM, GA, TX, FL, IL, VA and LA.

Timeline

Recall initiated: 2011-01-24
Posted by FDA: 2011-04-06
Terminated: 2012-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97884. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.