Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s: TD-100: PCBA Lot 60 TD-100: PCBA Lot 61 TD-100: PCBA Lot 62 TD-100: PCBA Lot 63 Optineb: PCBA Lot 72 Optineb: PCBA Lot 73 SERIAL NUMBERS: Kit S/N ML 1897 ML 1898 ML 1894 ML 1895 ML 1896 TD-100 S/N's 23103954 23103976 23104015 23104017 23104006 23104000 23103995 23104018 23104016 Optineb devices shipped to Caremark: Kit S/N ML 3660 MP 3662 ML 3665 MP 3667 MP 3668 MP 3676 MP 3683 MP 3690 ML 3691 MP 3692 Optineb S/N's 20900207 20900212 20900219 20900222 20900226 20900209 20900213 20900225 20900227 20900241 20900310 20900295 20900293 20900291 20900240 20900308 20900294 20900292 20900290 Kit S/N 3697 MP 3698 ML 3699 MP 3700 MP 3708 MP Optineb S/N's 20900262 20900283 20900285 20900265 20900253 20900264 20900284 20900286 20900268 20900315 NPR Device Not Part of Recall MP=Mount Prospect; ML-Monroeville TD-100 devices shipped to Accredo: Kit S/N 1879 1880 1881 1882 1883 1884 1885 1886 1887 TD-100 S/N's 23103982 23103985 23103988 23103990 23103992 23103984 23103986 23103989 23103991 23103993 23103959 23103961 23103963 23103994 23103958 23103960 23103962 23103972 Kit S/N 1888 1889 1890 1891 1892 1893 1899 1900 1901 TD-100 S/N's 23103970 23103997 23103996 23104022 23104019 23103975 23103998 23103999 23104024 23104020 23104014 23103981 23103980 23103974 23104013 23103978 23103973 23103964 Kit S/N 1902 1903 1904 1905 1906 1907 1908 1909 1910 TD-100 S/N's 23103966 23103968 23103956 23103952 23103950 23103967 23103977 23103957 23103955 23103951 23103948 23103945 23103941 23103943 23103942 23103940 23103944 Kit S/N 1911 1912 1913 1914 1916 1917 1918 1919 1921 TD-100 S/N's 23103947 23103949 23103939 23103946 23104001 23103965 23103969 23104002 23104005 23104003 23104011 23104007 23104008 TD-100 devices shipped to Accredo (continued): Kit S/N 1922 1923 1933 1934 TD-100 S/N's 23104012 23104009 23103937 23103938 23104025 23104010 Kit S/N 1935 1939 2175 2176 2178 2212 2227 2228 TD-100 S/N's 23104030 23104027 23101851 23103987 23103971 23104028 23103700 23103608 23103979 23103334 23103439 23101566 23103672 Kit S/N 2229 2311 2364 2481 2491 TD-100 S/N's 23103686 23103684 23104026 23104029 23104004 Optineb devices shipped to Accredo: Kit S/N 3658 3659 3661 3669 3670 3672 3674 3675 3680 Optineb S/N's 20900203 20900205 20900210 20900228 20900230 20900204 20900206 20900211 20900229 20900231 20900235 20900223 20900239 20900252 20900236 20900202 20900224 20900250 Kit S/N 3681 3682 3687 3694 3696 3702 3703 3704 Optineb S/N's 20900249 20900311 20900298 20900256 20900260 20900254 20900312 20900300 20900257 20900261 20900273 20900275 20900277 20900272 20900274 20900276 Optineb devices shipped to Curascript: Kit S/N 3657 3666 3671 3673 3677 3679 3685 3686 3689 Optineb S/N's 20900200 20900220 20900232 20900237 20900242 20900201 20900221 20900234 20900238 20900243 20900247 20900305 20900302 20900297 20900246 20900304 20900301 20900296 Kit S/N 3693 3701 3706 3709 Optineb S/N's 20900255 20900269 20900281 20900313 20900282 20900270 20900287 20900314
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- United Therapeutics Corp.
- Reason for Recall:
- Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709
Product Codes/Lot Numbers:
Lot #s: TD-100: PCBA Lot 60 TD-100: PCBA Lot 61 TD-100: PCBA Lot 62 TD-100: PCBA Lot 63 Optineb: PCBA Lot 72 Optineb: PCBA Lot 73 SERIAL NUMBERS: Kit S/N ML 1897 ML 1898 ML 1894 ML 1895 ML 1896 TD-100 S/N's 23103954 23103976 23104015 23104017 23104006 23104000 23103995 23104018 23104016 Optineb devices shipped to Caremark: Kit S/N ML 3660 MP 3662 ML 3665 MP 3667 MP 3668 MP 3676 MP 3683 MP 3690 ML 3691 MP 3692 Optineb S/N's 20900207 20900212 20900219 20900222 20900226 20900209 20900213 20900225 20900227 20900241 20900310 20900295 20900293 20900291 20900240 20900308 20900294 20900292 20900290 Kit S/N 3697 MP 3698 ML 3699 MP 3700 MP 3708 MP Optineb S/N's 20900262 20900283 20900285 20900265 20900253 20900264 20900284 20900286 20900268 20900315 NPR Device Not Part of Recall MP=Mount Prospect; ML-Monroeville TD-100 devices shipped to Accredo: Kit S/N 1879 1880 1881 1882 1883 1884 1885 1886 1887 TD-100 S/N's 23103982 23103985 23103988 23103990 23103992 23103984 23103986 23103989 23103991 23103993 23103959 23103961 23103963 23103994 23103958 23103960 23103962 23103972 Kit S/N 1888 1889 1890 1891 1892 1893 1899 1900 1901 TD-100 S/N's 23103970 23103997 23103996 23104022 23104019 23103975 23103998 23103999 23104024 23104020 23104014 23103981 23103980 23103974 23104013 23103978 23103973 23103964 Kit S/N 1902 1903 1904 1905 1906 1907 1908 1909 1910 TD-100 S/N's 23103966 23103968 23103956 23103952 23103950 23103967 23103977 23103957 23103955 23103951 23103948 23103945 23103941 23103943 23103942 23103940 23103944 Kit S/N 1911 1912 1913 1914 1916 1917 1918 1919 1921 TD-100 S/N's 23103947 23103949 23103939 23103946 23104001 23103965 23103969 23104002 23104005 23104003 23104011 23104007 23104008 TD-100 devices shipped to Accredo (continued): Kit S/N 1922 1923 1933 1934 TD-100 S/N's 23104012 23104009 23103937 23103938 23104025 23104010 Kit S/N 1935 1939 2175 2176 2178 2212 2227 2228 TD-100 S/N's 23104030 23104027 23101851 23103987 23103971 23104028 23103700 23103608 23103979 23103334 23103439 23101566 23103672 Kit S/N 2229 2311 2364 2481 2491 TD-100 S/N's 23103686 23103684 23104026 23104029 23104004 Optineb devices shipped to Accredo: Kit S/N 3658 3659 3661 3669 3670 3672 3674 3675 3680 Optineb S/N's 20900203 20900205 20900210 20900228 20900230 20900204 20900206 20900211 20900229 20900231 20900235 20900223 20900239 20900252 20900236 20900202 20900224 20900250 Kit S/N 3681 3682 3687 3694 3696 3702 3703 3704 Optineb S/N's 20900249 20900311 20900298 20900256 20900260 20900254 20900312 20900300 20900257 20900261 20900273 20900275 20900277 20900272 20900274 20900276 Optineb devices shipped to Curascript: Kit S/N 3657 3666 3671 3673 3677 3679 3685 3686 3689 Optineb S/N's 20900200 20900220 20900232 20900237 20900242 20900201 20900221 20900234 20900238 20900243 20900247 20900305 20900302 20900297 20900246 20900304 20900301 20900296 Kit S/N 3693 3701 3706 3709 Optineb S/N's 20900255 20900269 20900281 20900313 20900282 20900270 20900287 20900314
Distribution:
Distributed in: TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1423-2014
Related Recalls
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
CGMP Deviations