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Recall Observatory FDA recall evidence

Device product

Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA

Z-2244-2017

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-2244-2017

Official wording

Reason: Unavailable

Code information: Lot Number (Product Code 9106-E) 100168, 101193, 101896; (Product Code 9108-E) 102143, 103119, 103378, 104273, 104839, 104879, 105224; (Product Code ZRNRMA) 101060, 103355, 104768, 105655

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