Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;

FDA device recall Z-2228-2017 · posted 2017-05-24 · Terminated

Recall details

Recalling firm

ConvaTec, Inc

Reason for recall

Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.

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

Quantity affected

816,709

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