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Terminated

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

FDA Recall Z-1255-2011 · Posted 2011-02-15

Recalling FirmConvatec Inc.
Recall StatusTerminated
Product CodeBYL
Date Initiated2011-01-07
Date Terminated2013-02-27
Product Quantity1579100 pcs.

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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