Universal F2 Anesthesia Breathing Circuit, REF 5D440-61X-17, Manufacturer: King Systems, Nobleville, IN. An oxygen mask

FDA device recall Z-1891-2011 · posted 2011-04-06 · Terminated

Recall details

Recalling firm

King Systems Corp.

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.

Action taken

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

Status

Terminated

Product code

BYG

Quantity affected

416 cases of 30 per case 12480 units

Distribution

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

Date initiated

2011-01-24

Date posted

2011-04-06

Date terminated

2012-08-14

Location

Noblesville, IN