Recall Z-1887-2011 ยท BYG Mask, Oxygen
King Systems Corp.
Face Tent with 15 mm Adapter, REF 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.
| Date | Apr 6, 2011 (initiated Jan 24, 2011) |
| Status | Terminated |
| Reason | 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 | Other |
| 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 r |
| Quantity | 1198 cases of 50 per case 59,900 |
| Distribution | Nationwide Distribution -- NM, GA, TX, FL, IL, VA and LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.