Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses

FDA device recall Z-1044-2016 · posted 2016-03-03 · Terminated

Recall details

Recalling firm

ConvaTec, Inc

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LCQ

Quantity affected

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: Au

Date initiated

2015-11-11

Date posted

2016-03-03

Date terminated

2016-07-18

Location

Greensboro, NC

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