FDA Medical Device Recalls (openFDA)
ConvaTec, Inc: Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
- Recall number
- Z-2238-2017
- Recalling firm
- ConvaTec, Inc
- Product
- Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
- Status
- Terminated
- Initiated
- 2017-05-10
- Posted
- 2017-05-24
- Terminated
- 2021-08-27
- Reason
- not on file
- Root cause
- Process control
- Action
- Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
- Quantity
- not on file
- 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
- Lot, serial or model codes
- Lot Number (Product Code 3108-E) 100132, 104079, 105936; (Product Code 3108MM) 103715; (Product Code 86-106E) 100056, 101452, 101725, 102695, 103006, 104041, 104198, 104634, 104969, 105687; (Product Code 86-108E) 100057, 100200, 101453, 101726, 102080, 102477, 102566, 102696, 103005, 103549, 104042, 104199, 104450, 104694, 104847, 104971, 105596, 105688; (Product Code LM-86-106) 100138, 102215, 102866, 104160, 105169; (Product Code PMD06002) 100551; (Product Code PMD06003) 100550
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BYG
- Firm FEI
- 3011987967
- Firm city
- Greensboro
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28