Recall Z-1044-2016
ConvaTec, Inc · initiated November 11, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: lot/batch numbers 13-23, 13-24, 13-29, 13-30, 13-31, 13-32, 97750, 97774, 97777, 97870, 97871, 97873, 97874, 97880, 97988, 98030, 98031, 98033, 98034, 98043, 98048, 98058, 98059, 98099, 98103, 98330, 98338, 98380, 98491, 98520, 98546, 98556, 98570, 98571, 98578, 98595, 98635, 98683, 98694, 98721, 98722, 98730, 98733, 98738, 98777, 98779, 98782, 98840, 98841, 98843, 98844, 98853, 98856, 98859, 98867, 98868, 98869, 98870, 98871, 98969, 99078, 99079, 99199, 99206, 99207, 99227, 99230, 99231, 99232, 99297, 99397, 99398, 99447, 99450, 99451, 99466, 99492, 99539, 99577, 99578, 99591, 99606, 99628, 99630, 99631, 99642, 99661, 99673, 99674, 99708, 99709, 99735, 99845, 99852, 99853, 99854, 99919, 99920, 99928, 99932, 99997, 100029, 100065, 100066, 100074, 100077, 100101, 100102, 100114, 100119, 100155, 100167, 100177, 100180, 100205, 100206, 100207, 100238, 100254, 100401, 100402, 100424, 100483, 100506, 100516, 100546, 100549, 100552, 100563, 100599, 100603, 100693, 100697, 100700, 100705, 100752, 100759, 100784, 100809, 100812, 100814, 100871, 100931, 100984, 100985, 101186, 101200, 101201, 101202, 101310, 101312, 101450, 101473, 101474, 101484, 101485, 101527, 101528, 101533, 101537…
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 recall). If you want replacement product contact customer service by phone at 1-800-634-6003, extension 1103 or by email at respiratoryorders@convatec.com. If you have any questions call 1-877-650-3492.
Details
- Recall number
- Z-1044-2016
- Initiated
- November 11, 2015
- Posted by FDA
- March 3, 2016
- Terminated
- July 18, 2016
- Product code
- LCQ – Fluorescent Immunoassay Gentamicin
- 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, Israel, Italy, Jordan, Kenya, Kuwait, Netherlands, Norway, Russia, Saudi Arabia, Sweden…
- Recalling firm
- ConvaTec, Inc, Greensboro, NC