Z-1126-04

Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves...

Name: Z-1126-04 Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves...
Creator: Medex Inc
Published: 2004-07-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-07-12 / Terminated / root cause: labeling and UDI

FDA source

Medex Inc began a recall of Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84'' Tube (3 in 1 mask); reorder no. 7020; SIngle... on 2004-07-12. The reason FDA records is "The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1126-04
Status: Terminated
Initiated: 2004-07-12
Posted: 2004-07-22
Terminated: 2005-02-07
Recalling firm: Abbott Medical
Product: Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84'' Tube (3 in 1 mask); reorder no. 7020; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008
Product code: KGB Mask, Oxygen, Non-Rebreathing
Reason for recall: The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.
Quantity in commerce: 1,452 units
Distribution: California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.
Product codes and lots: reorder no. 7020, lots K235, K277A, J135R, J142, M196, M337, N107

Product code KGB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)