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Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All

FDA device recall Z-2242-2017 · posted 2017-05-24 · Terminated

Recall details

Recalling firm
ConvaTec, Inc
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.
Root cause
Process control
Status
Terminated
Product code
BYG
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,
Date initiated
2017-05-10
Date posted
2017-05-24
Date terminated
2021-08-27
Location
Greensboro, NC

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