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Recall Observatory FDA recall evidence

Device product

Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM

Z-2233-2017

May 10, 2017

Class II

Product summary

Firm
ConvaTec, Inc
Event
Event 77282
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2233-2017

Official wording

Reason: Unavailable

Code information: Lot Number 100281, 100709, 100729, 101923, 103180, 103265, 103691, 103714, 104104, 105987, 110558

Distribution pattern: CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam