Convatec Inc.: 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

Recall number

Z-1256-2011

Recalling firm

Convatec Inc.

Product

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

Status

Terminated

Initiated

2011-01-07

Posted

2011-02-15

Terminated

2013-02-27

Reason

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

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

1113200 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.

Lot, serial or model codes

Numerous lots produced between June 2009 and September 2010.

510(k) numbers

not on file

PMA numbers

not on file

Product code

BYG

Firm FEI

3011987967

Firm city

Skillman

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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