FDAClass IIJune 14, 2017

Non-Rebreather Mask w 7 recall

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

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

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