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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

Field note

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