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U.S. Department of Health and Human Services

Class 2 Device Recall Hospilak, Portex First Breath, MediChoice

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 Class 2 Device Recall Hospilak, Portex First Breath, MediChoicesee related information
Date Initiated by FirmJanuary 07, 2011
Date PostedFebruary 15, 2011
Recall Status1 Terminated 3 on February 27, 2013
Recall NumberZ-1255-2011
Recall Event ID 57626
Product Classification oxygen mask - Product Code BYL
ProductFace 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
Code Information Numerous lots produced between June 2009 and September 2010.
Recalling Firm/
Manufacturer		 Convatec Inc.
200 Headquarters Park Drive
Skillman NJ 08558-2600
For Additional Information ContactMs. Barbara DeLade
908-904-2675
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionUnomedical, 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 Commerce1579100 pcs.
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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