Device Recall MADA, Hospilak, respirex, Trianim, McKesson, optimist, portex, medichoice

Numerous lots produced between June 2009 and September 2010.

Anesthesiology Devices

1

No

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.

Oxygen Masks- Labeling as follows: || MADA, Inc. || Adult Medium Concentration Oxygen Mask with Non-crush 7 Coiled Tubing, Connector Both Ends No 1327; || RESPIREX || Aerosol Mask Adult Elongated Manufactured for PSS World Medical Inc. || RESPIREX || Nebulizer Kits w/Aerosol Mask || Adult || 7 ft. (2.1m) Aerosol Tubing || Manufactured for PSS World Medical Inc. || Unomedical, Inc., Hospilak REF 100-E Aerosol Mask Adult || Unomedical, Inc., Hospilak Ref. No. 101-E, Adult Aerosol Mask w/Aerosol Connector, 15 mm; || Unomedical, Inc., Hospilak Ref. No. 102-E, Medium Concentration Mask, Adult 7 (2.1m) Tubing || Unomedical, Inc., Hospilak Ref. No. 103-E, Medium Concentration Mask, Adult || Unomedical, Inc., Hospilak REF 104-E High Concentration Rebreather Oxygen Mask, Adult w/7 (2.1)m) Oxygen Tubing, || Unomedical, Inc., Hospilak Ref. No. 105-E, High Concentration Rebreather Oxygen Mask, Adult, No Tubing || Unomedical, Inc., Hospilak Ref. No. 106-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing || Unomedical, Inc., Hospilak Ref. No. 108-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing || Unomedical, Inc., Hospilak Ref. No. 118-E, Aerosol Mask Elongated, Adult 6 (1.8 m) Aerosol Tubing || Unomedical, Inc., Hospilak Ref. No. 120-E, Venturi Mask Kit, Adult All Diluters No-Crush || MADA INC. Aerosol Mask, Adult Size, Elongated MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use || MADA INC. Aerosol Mask, Pediatric Size, Elongated No 1327 100% Latex Free MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use || MADA INC. Up- Mist Medication Nebulizer With 7 ft. Oxygen Tubing and Elongated Aerosol Mask No. 1310MA 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use || MADA INC Up-Mist Medication Nebulizer with 7 ft. Oxygen Tubing and Pediatric Aerosol Mask No. 1310 NMP 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use || Unomedical, Inc., Hospilak REF No. 131-E, Venturi Mask Kit, Adult with 31% diluter only, || MADA, Inc. Child/Pediatric Medium Concentration Oxygen Mask with Non-Crush 7 Coiled Tubing, Connector Both Ends, NO 1327C, || Unomedical, Inc., Hospilak REF No. 182-E, 3-in-1 Emergency Mask, Elongated Adult, 7 (2.1m) Oxygen Tubing, || Unomedical, Inc., Hospilak REF No. 200-E, Aerosol Mask, Adult Small, No Tubing, || Unomedical, Inc., Hospilak REF No. 202-E, Medium Concentration Oxygen Mask, || Adult with 7 (2.1m) Oxygen Tubing, || Unomedical, Inc., Hospilak REF No. 220-E, Aerosol Mask, Pediatric, No Tubing, || Unomedical, Inc., Hospilak REF No, 221-E, Aerosol Mask Elongated, Pediatric 5 (1.5m) Aerosol Tubing || Unomedical, Inc., Hospilak REF No. 222-E, Medium Concentration Oxygen Mask, Pediatric with 7 (2.1m) Oxygen Tubing, || Unomedical, Inc., Hospilak REF No. 223-E, Medium Concentration Oxygen Mask, Pediatric No Tubing, || Unomedical, Inc., Hospilak REF No. 228-E, Up-Mist Nebulizer with 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask Elongated || Unomedical, Inc., Hospilak REF No. 245-E, Adult Trach Mask || Unomedical, Inc., Hospilak REF No. 246-E, Pediatric Trach Mask || Unomedical, Inc., Hospilak REF No. 260-E, Aerosol Mask, Infant No Tubing, || Unomedical, Inc., Hospilak REF No. 263-E, Medium Concentration Mask Infant, No Tubing, || Unomedical, Inc., Hospilak REF No. 282-E, 3 in 1 Emergency Mask, Elongated Pediatric, 7 (2.1m) Oxygen Tubing || TRI-ANIM Adult Aerosol Mask Elongated adult aerosol mask with elastic strap and adjustable noseclip Part Number 301-170 50/case eValueMed || Tri-anim Pediatric Aerosol Mask Elongated pediatric aerosol mask with elastic strap and adjustable noseclip Part Number 301-171 50/case eValueMed || Tri-anim Adult Oxygen Mask Elongated adult medium mask with elastic strap and adjustable noseclip Part Number 301-180 eVal