Reported Jul 16, 2014 · Terminated
Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use…
United Therapeutics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: United Therapeutics Corp. · 55 Tw Alexander Dr · Research Triangle Park, NC · 27709-0152
Is this the product you have?
- 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
- Lot codes and dates
- Lot #s:
- TD-100PCBA
- Lot 60 TD-100PCBA
- Lot 61 TD-100PCBA
- Lot 62 TD-100PCBA
- Lot 63 OptinebPCBA
- Lot 72 OptinebPCBA
- Lot 73 SERIAL NUMBERSKit S/N ML 1897 ML 1898 ML 1894 ML 1895 ML 1896 TD-100 S/N's
231039542310397623104015231040172310400623104000231039952310401823104016
- Optineb devices shipped to CaremarkKit 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'sKit S/N 3697 MP 3698 ML 3699 MP 3700 MP 3708 MP Optineb S/N's
20900207209002122090021920900222209002262090020920900213209002252090022720900241209003102090029520900293209002912090024020900308209002942090029220900290
NPR Device Not Part of Recall MP=Mount Prospect; ML-Monroeville20900262209002832090028520900265209002532090026420900284209002862090026820900315
- TD-100 devices shipped to AccredoKit S/NS/N's
187918801881188218831884188518861887TD-100
Kit S/N231039822310398523103988231039902310399223103984231039862310398923103991231039932310395923103961231039632310399423103958231039602310396223103972
S/N's188818891890189118921893189919001901TD-100
Kit S/N231039702310399723103996231040222310401923103975231039982310399923104024231040202310401423103981231039802310397423104013231039782310397323103964
S/N's190219031904190519061907190819091910TD-100
Kit S/N2310396623103968231039562310395223103950231039672310397723103957231039552310395123103948231039452310394123103943231039422310394023103944
S/N's191119121913191419161917191819191921TD-100
23103947231039492310393923103946231040012310396523103969231040022310400523104003231040112310400723104008TD-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/NS/N's
19351939217521762178221222272228TD-100
Kit S/N 2229 2311 2364 2481 2491 TD-100 S/N's 23103686 23103684 23104026 23104029 2310400423104030231040272310185123103987231039712310402823103700231036082310397923103334231034392310156623103672
- Optineb devices shipped to AccredoKit S/NOptineb S/N's
365836593661366936703672367436753680
Kit S/N209002032090020520900210209002282090023020900204209002062090021120900229209002312090023520900223209002392090025220900236209002022090022420900250
Optineb S/N's36813682368736943696370237033704
20900249209003112090029820900256209002602090025420900312209003002090025720900261209002732090027520900277209002722090027420900276
- Optineb devices shipped to CurascriptKit S/NOptineb S/N's
365736663671367336773679368536863689
Kit S/N 3693 3701 3706 3709 Optineb S/N's209002002090022020900232209002372090024220900201209002212090023420900238209002432090024720900305209003022090029720900246209003042090030120900296
2090025520900269209002812090031320900282209002702090028720900314
- Amount recalled
- 188 Units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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