Z-1255-2011

Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical inc. Hospilak Ref...

Name: Z-1255-2011 Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical inc. Hospilak Ref...
Creator: Convatec Inc.
Published: 2011-01-07
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2011-01-07 / Terminated / root cause: manufacturing process

FDA source

Convatec Inc. began a recall of Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical inc. Hospilak Ref. No. 111-E, Face Tent, Adult No Tubing, with 15mm... on 2011-01-07. The reason FDA records is "Face tents and Oxygen masks may have a sticky glue-like substance on the inside or outside of the mask consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monoleate". 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-1255-2011
Status: Terminated
Initiated: 2011-01-07
Posted: 2011-02-15
Terminated: 2013-02-27
Recalling firm: ConvaTec Limited
Product: Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical inc. Hospilak Ref. No. 111-E, Face Tent, Adult No Tubing, with 15mm OD Connector Manufactured for Unomedical inc. Hospilak Ref. No. 115-E, Face Tent, Adult 5 (1.5m) Tubing Manufactured for Unomedical inc. Hospilak Ref. No. 116-E, Face Tent, Adult 6 (1.8 m) Aerosol Tubing Manufactured for Unomedical inc. McKesson Aerosol Mask, Face Tent Adult, No Tubing Reorder No. 86-110E Face Tent Adult, 6 (1.8m) Aerosol Tubing Reorder no. 86-116E Smiths Medical Portex First Breath Adult Face Tent (Non-latex) Ref 001490 Smiths Medical Portex First Breath Adult Face Tent with Tubing, 188cm (5 ft.) (Non-latex) Ref 001492 Owens & Minor MediChoice Adult Face Tent Re-Order #RSP3000 and Face Tent, Adult 6 (1.8m) Aerosol Tubing Re-Order #RSP3060
Product code: BYL Tent, Oxygen
Reason for recall: Face tents and Oxygen masks may have a sticky glue-like substance on the inside or outside of the mask consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monoleate.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Unomedical, Inc issued recall letters with attached return response forms dated January 7, 2011 via UPS. The letters request the customer stop use and quarantine product. The recall response form is to be completed and returned to Unomedical. The letters/return response form were also sent out in Spanish. Another recall letter was sent dated February 16, 2011 to capture additional lots that werent included in the initial letter.
Quantity in commerce: 1579100 pcs.
Distribution: Worldwide distribution, including USA, Puerto Rico, Canada, Mexico, Colombia, El Salvador, Paraguay, UK, Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden and Switzerland, Israel, Jordan, Lebanon, Libya, Morocco, Saudi Arabia, United Arab Emirates, Russia, Australia, New Zealand, Japan and Vietnam.
Product codes and lots: Numerous lots produced between June 2009 and September 2010.

Product code BYL

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)