FDAClass IIJune 14, 2017

Rebreather Oxygen Mask recall

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

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

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