FDAClass IIJune 14, 2017

Non-Rebreathing Mask recall

Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM

Why was it recalled?

The source record does not provide a concise hazard summary.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM
Recalling firm
ConvaTec, Inc
Quantity
N/A
Distribution
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
Recall date
June 14, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls