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Recall Observatory FDA recall evidence

Device product

Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001

Z-2236-2017

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-2236-2017

Official wording

Reason: Unavailable

Code information: Lot Number (Product Code 3104MM) 103665; (Product Coe 9104-E) 100130, 101056, 101638, 102066, 104977; (Product Code PMD06001) 100914

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