The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2241-2017·Announced 2017-06-14

ConvaTec Recalls Non-Rebreathing Masks Due to Potential Valve Defects

ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreathing Masks with tubing. The recall is classified as Class II by the FDA.

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 where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source does not report specific injuries or deaths, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported or is theoretical.

Plain-English summary

ConvaTec, Inc. is voluntarily recalling Non-Rebreathing Masks, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM. The affected units are identified by Lot Numbers 104906 and 105181. The recall was initiated on May 10, 2017, and was classified as Class II by the FDA on June 2, 2017.

The source text does not specify the exact reason for the recall or the specific defect involved. The recall status is listed as Terminated as of August 27, 2021.

The affected products were distributed in the United States (CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA, 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 and healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices if found.

The recalled product

Product
Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
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 (2)

  • Lot Number  104906
  • 105181

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 →

Related recalls

Same manufacturer · ConvaTec, Inc

See all →

Same hazard · device defect

See all →

Similar recalls