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Recall Observatory FDA recall evidence

Device product

Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM

Z-2230-2017

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-2230-2017

Official wording

Reason: Unavailable

Code information: Lot Number (Product Code 106-E), 100152, 102095, 102154, 103122, 103159, 103385, 103527, 103558, 104009, 104321, 104322, 104328, 104701, 104975, 105569, 105656, 1045675; (Product Code 3226MM) 100720, 101141; (Product Code 9108MM) 100232, 100694, 100918, 101639, 101897, 103067, 104846, 104848, 105453

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

Field note

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