FDA Enforcement
Class II
Terminated
Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E
Recall: Z-2245-2017
·
Reported June 14, 2017
Enforcement
- Recall Number
- Z-2245-2017
- Event ID
- 77282
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- ConvaTec, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 14, 2017
- Initiation Date
- May 10, 2017
- Classification Date
- June 2, 2017
- Termination Date
- August 27, 2021
- Address
- 7900 Triad Center Dr Ste 400, N/A, Greensboro, NC, 27409-9076, United States
Description
Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E
Code Info
Lot Number 100150, 100478, 100775, 101054, 101057, 101700, 101705, 103210, 103379, 103762, 105485
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
Quantity
N/A