FDAClass IIJuly 30, 2014

Oxygen Mask recall

Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap…

Why was Oxygen Mask recalled?

The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.

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 numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614

Product
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap…
Recalling firm
Salter Labs
Quantity
584 units
Distribution
Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.
Recall date
July 30, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls