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Recall Observatory FDA recall evidence

Device product

Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E

Z-2232-2017

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-2232-2017

Official wording

Reason: Unavailable

Code information: Lot Number 100454, 100734, 101053, 101121, 101607, 101665, 101999, 102352, 102726, 102766, 102785, 103179, 103254, 103529, 104103, 104457, 104653, 104706, 104799, 105213, 105283, 105315, 105451, 105676, 109186

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