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
This recall has been terminated (originally issued May 24, 2017).
- Company
- Convatec, Inc
- Recall Initiated
- May 10, 2017
- Posted
- May 24, 2017
- Terminated
- August 27, 2021
- Recall Number
- Z-2238-2017
- Firm Location
- Greensboro, NC
- Official Source
- View on FDA website ↗
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 / Code Info
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
Root Cause
Process control
Action Taken
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.