ConvaTec Recalls Adult Non-Rebreather Masks Due to Defect
ConvaTec, Inc. is voluntarily recalling adult non-rebreather masks with 'No-Crush' tubing. The recall was initiated in May 2017 and is now terminated.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences. Per the rubric, this aligns with a 'High' severity score, as it is not a Class I (Critical) or Class III (Low/Moderate) recall.
Plain-English summary
ConvaTec, Inc. is voluntarily recalling specific lots of adult non-rebreather masks with 7-foot (2.1 m) 'No-Crush' tubing. The affected products include Product Codes 9106-E, 9108-E, and ZRNRMA. The recall was initiated on May 10, 2017, and was classified as Class II by the FDA. The recall status is currently terminated.
The specific reason for the recall is not detailed in the provided source text. The affected units were distributed across 13 U.S. states, Puerto Rico, and 24 international countries, including Australia, Canada, and the United Kingdom. Specific lot numbers are listed for each product code in the official recall record.
Consumers and healthcare providers should check their inventory for the specific product codes and lot numbers listed in the recall notice. As the recall is terminated, the firm has completed the necessary corrective actions. No specific instructions for end-users are provided in the source text beyond the identification of the affected lots.
The recalled product
- Product
- Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA
- Manufacturer
- ConvaTec, Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Part of a larger recall action
This product is one of 18 recalled by ConvaTec, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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