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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