Z-2228-2017Class II

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

Name: Z-2228-2017 Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E
Creator: ConvaTec, Inc
Published: 2017-05-10
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2017-05-10 / Terminated / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E on 2017-05-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2228-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-10
Posted: 2017-05-24
Terminated: 2021-08-27
Recalling firm: ConvaTec Limited
Product: Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Product code: BYG Mask, Oxygen
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
Product codes and lots: Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2228-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2228-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2229-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2230-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2231-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2232-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2233-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2234-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2235-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2236-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2237-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2238-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2239-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2240-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2241-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2242-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2243-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2244-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02
Z-2245-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02

Product code BYG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)