The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2229-2017·Announced 2017-06-14

ConvaTec Recalls Rebreathing Masks with Reservoir Bags and Tubing

ConvaTec, Inc. is voluntarily recalling Rebreathing Masks, Reservoir bags, with Tubing (Product Code 104MM) due to a Class II safety concern.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 could cause temporary or medically reversible adverse health consequences. Per the rubric, Class II recalls without specific reports of hospitalization or death are typically scored as High (3) or Severe (4); given the lack of explicit injury reports in the text, High is the appropriate classification for a risk-of-harm product where injury has not yet been reported or specified.

Plain-English summary

ConvaTec, Inc. is voluntarily recalling Rebreathing Masks, Reservoir bags, with Tubing, Product Code 104MM. The recall was initiated by the firm on May 10, 2017, and was classified as Class II by the U.S. Food and Drug Administration. The specific lot number affected is 105631.

The source text does not specify the exact reason for the recall or the specific hazard associated with the product. The recall status is currently terminated, with a termination date of August 27, 2021.

The affected products were distributed in the United States (including California, Connecticut, Florida, Georgia, Illinois, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Virginia, and Puerto Rico) and internationally in 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. Consumers should check their products for Lot Number 105631 and contact ConvaTec, Inc. for further instructions.

The recalled product

Product
Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
Manufacturer
ConvaTec, Inc
Category
Medical Device — Respiratory Equipment
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 (1)

  • Lot Number 105631

Distribution

Distributed in 14 states:

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.

See all 18 products in this recall →

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