Z-2654-2011

First Breath Adult Face Tent with Tubing 188cm (5ft.) (Non-latex) Reorder Number: 001492 Face Tent Is a...

Name: Z-2654-2011 First Breath Adult Face Tent with Tubing 188cm (5ft.) (Non-latex) Reorder Number: 001492 Face Tent Is a...
Creator: Smiths Medical
Published: 2011-02-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-02-11 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical began a recall of First Breath Adult Face Tent with Tubing 188cm (5ft.) (Non-latex) Reorder Number: 001492 Face Tent Is a special type of aerosol mask used when the delivery of... on 2011-02-11. The reason FDA records is "A sticky substance on the inside and/ or outside of the Mask". 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-2654-2011
Status: Terminated
Initiated: 2011-02-11
Posted: 2011-06-24
Terminated: 2018-07-02
Recalling firm: Abbott Medical
Product: First Breath Adult Face Tent with Tubing 188cm (5ft.) (Non-latex) Reorder Number: 001492 Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Normally this type of mask is used to deliver an aerosol mist to cool and moisturize the nasal passages or sinuses after surgery
Product code: BYG Mask, Oxygen
Reason for recall: A sticky substance on the inside and/ or outside of the Mask
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Smiths Medical notified consignees by letter on 2/14/11 titled Urgent Medical Device Correction Notice via U.S. Mail (USA only) This Notice includes an Urgent Medical Device Correction Notice Confirmation Form that provides instructions to consignees to return unused affected product to Smiths Medical and to complete the effectivity tracking form. On 3/17/11 Smiths Medical issued an additional recall letter to extend the recall to 3 additional lots not included in the original recall letter dated 2/14/11. Also, the firm issued a recall letter on 3/17/11 to include the Value Pack (VP1302) General Anesthesia Kit to include 7 kit lots. Contact Recall Coordinator 1-800-348-6064 prompt 4, ext 2273
Quantity in commerce: 600 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Armenia, Brazil, Canada, France, Hungary, Italy, Jordan, Japan, Libya, Poland, Russian Federation, and Saudi Arabia.
Product codes and lots: Lot Numbers: 10-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)