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Terminated

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.

FDA Recall Z-1044-2016 · Posted 2016-03-03

Recalling FirmConvaTec, Inc
Recall StatusTerminated
Product CodeLCQ
Date Initiated2015-11-11
Date Terminated2016-07-18
Product Quantity3,605,700 pieces

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.

Firm 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 [email protected] 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 [email protected]. If you have any questions call 1-877-650-3492.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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, Switzerland, United Kingdom & Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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