36 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Recall
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VariSoft infusion set, Model Number 1002827
FDA Recall
Open, Classified
·Unomedical A/S Aaholmvej·Product code FPA·October 11, 2023
VariSoft infusion set, Model Number 1002830
FDA Recall
Open, Classified
·Unomedical A/S Aaholmvej·Product code FPA·October 11, 2023
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
FDA Recall
Open, Classified
·Unomedical A/S Aaholmvej·Product code FPA·July 21, 2022
VariSoft infusion set, Model Number 1002828
FDA Recall
Open, Classified
·Unomedical A/S Aaholmvej·Product code FPA·October 11, 2023
VariSoft Infusion Set, Single Use.
FDA Recall
Open, Classified
·Unomedical A/S Osted Aholmvej 1·Product code FPA·July 23, 2024
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
FDA Recall
Open, Classified
·Unomedical A/S Osted Aholmvej 1·Product code FPA·March 5, 2024
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
FDA Recall
Terminated
·Convatec Inc.·Product code BYG·January 7, 2011
Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product ID # 779728
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Recall
Terminated
·Product code FPA·May 21, 2015
Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708. Packaged under the name of Evergreen.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Product ID# 12-8707. Packaged under the name of Evergreen.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow. Product ID # 12-8714; 731-E, 731MM; 86-731E. Packaged under the name of Evergreen, Hospitak and McKesson.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas Sampling Elbow. Product ID #: 728-E.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas sampling elbow. Foreign distribution only. Product code: 725-E,
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and swivel gas sampling elbow, Peep Valve. Product code: 40-116733, Distribution to France only.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas sampling elbow. foreign Distribution only: Product number 733-E.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Manual Pulmonary Resuscitator, Adult w/ Large Adult Mask & Reservoir Bag. Product # 12-8705. Packaged under the name of Evergreen.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009