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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

ConvaTec, Inc: Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.

Agency Publication Date: May 24, 2017
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Affected Products

Product: Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;

Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530

Lot Numbers:
Number
Product: Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM

Lot Number 105631

Lot Numbers:
Number
Product: Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM

Lot Number (Product Code 106-E), 100152, 102095, 102154, 103122, 103159, 103385, 103527, 103558, 104009, 104321, 104322, 104328, 104701, 104975, 105569, 105656, 1045675; (Product Code 3226MM) 100720, 101141; (Product Code 9108MM) 100232, 100694, 100918, 101639, 101897, 103067, 104846, 104848, 105453

Lot Numbers:
Number
106-E
3226MM
9108MM
Product: Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM

Lot Number 100721, 100733, 104106, 104798, 109824

Lot Numbers:
Number
Product: Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E

Lot Number 100454, 100734, 101053, 101121, 101607, 101665, 101999, 102352, 102726, 102766, 102785, 103179, 103254, 103529, 104103, 104457, 104653, 104706, 104799, 105213, 105283, 105315, 105451, 105676, 109186

Lot Numbers:
Number
Product: Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM

Lot Number 100281, 100709, 100729, 101923, 103180, 103265, 103691, 103714, 104104, 105987, 110558

Lot Numbers:
Number
Product: Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM

Lot Number 100919, 101880

Lot Numbers:
Number
Product: Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E

Lot Number  100163, 100464, 101671, 102011, 102397, 102787, 102856, 103850, 104901

Lot Numbers:
Number
Product: Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001

Lot Number (Product Code 3104MM) 103665; (Product Coe 9104-E) 100130, 101056, 101638, 102066, 104977; (Product Code PMD06001) 100914

Lot Numbers:
Number
3104MM
PMD06001
Product: Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E

Lot Number 100272, 100465, 101132, 101616, 101994, 102398, 102788, 102935, 103192, 103384, 103445, 103851, 103908, 104078, 104902, 104947, 105189, 105441, 105935

Lot Numbers:
Number
Product: Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003

Lot Number (Product Code 3108-E) 100132, 104079, 105936; (Product Code 3108MM) 103715; (Product Code 86-106E) 100056, 101452, 101725, 102695, 103006, 104041, 104198, 104634, 104969, 105687; (Product Code 86-108E) 100057, 100200, 101453, 101726, 102080, 102477, 102566, 102696, 103005, 103549, 104042, 104199, 104450, 104694, 104847, 104971, 105596, 105688; (Product Code LM-86-106) 100138, 102215, 102866, 104160, 105169; (Product Code PMD06002) 100551; (Product Code PMD06003) 100550

Lot Numbers:
Number
3108-E
3108MM
86-106E
86-108E
LM-86-106
PMD06002
PMD06003
Product: Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E

Lot Number  (Product Code 3224-E) 105215; (Product Code 3226-E) 100497, 100748, 101140, 102282, 102400, 102727, 102858, 103188, 103273, 103300, 103853, 104081, 104654, 104889, 105065, 105190, 105216, 13-34

Lot Numbers:
Number
3224-E
3226-E
Product: Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E

Lot Number  100214, 100316, 100467, 101619, 102605, 102728, 103190, 103451, 103852, 104083, 104905, 105142

Lot Numbers:
Number
Product: Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM

Lot Number  104906, 105181

Lot Numbers:
Number
Product: Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E

Lot Number  100071, 100242, 100253, 100601, 100749, 100811, 101143, 101480, 102711, 103195, 103275, 103324, 105511, 105571, 105660

Lot Numbers:
Number
Product: Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106

Lot Number (Product Code 86-3226E) 100050, 100196, 102698, 103003, 104062, 104331, 104424, 104928, 105597; (Product Code PMD06009) 100574; (Product Code PMD06106) 100581

Lot Numbers:
Number
86-3226E
PMD06009
PMD06106
Product: Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA

Lot Number (Product Code 9106-E) 100168, 101193, 101896; (Product Code 9108-E) 102143, 103119, 103378, 104273, 104839, 104879, 105224; (Product Code ZRNRMA) 101060, 103355, 104768, 105655

Lot Numbers:
Number
9106-E
9108-E
ZRNRMA
Product: Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E

Lot Number 100150, 100478, 100775, 101054, 101057, 101700, 101705, 103210, 103379, 103762, 105485

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77282
Status: Resolved
Manufacturer: ConvaTec, Inc
Manufactured In: United States
Units Affected: 816,709

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.