Recall Z-1044-2016 ยท LCQ Fluorescent Immunoassay Gentamicin
ConvaTec, Inc
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
| Date | Mar 3, 2016 (initiated Nov 11, 2015) |
| Status | Terminated |
| Reason | The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, ConvaTec, sent each consignee affected by the recall an overnight express mail "Urgent Voluntary Recall Notice" and Response Form dated 12/7/2015. The notice described the product, problem and actions to be taken. The recall notice instructed the consignee to immediately stop distributing and quarantine all affected lots; perform a count of all recalled product currently in inventory; complete and return the enclosed Recall Response Form by email at convatec3657@stericyle.com or by fax at 1-888-603-8986, and return all affected product, (ONLY return the lots affected with this recal |
| Quantity | 3,605,700 pieces |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, ME, MA, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TX VA, WA, WI, and countries of: Australia, Belgium, Burma, Canada, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, Germany, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K801867 | DISPOSABLE MEDICATION NEBULIZER Hospitax, Aug 20, 1980 |