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Recall Observatory FDA recall evidence

Device product

Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E

Z-2239-2017

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-2239-2017

Official wording

Reason: Unavailable

Code information: Lot Number  (Product Code 3224-E) 105215; (Product Code 3226-E) 100497, 100748, 101140, 102282, 102400, 102727, 102858, 103188, 103273, 103300, 103853, 104081, 104654, 104889, 105065, 105190, 105216, 13-34

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