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Terminated

Aerosol mask with 15 mm adapter, REF S-MD127, 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 Recall Z-1890-2011 · Posted 2011-04-06

Recalling FirmKing Systems Corp.
Recall StatusTerminated
Product CodeBYG
Date Initiated2011-01-24
Date Terminated2012-08-14
Product Quantity43 cases of 5 per case 215 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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