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