Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Check against the official notice below — it lists the full affected range.
Cook Incorporated is recalling 11,451 units of its Pressure Monitoring Set, Single-lumen uncoated central venous catheter (model RPN C-PMS-250, GPN G02838) distributed nationwide in the US, Brazil, and Canada. The products may contain excess coating material on the outside and/or interior of the needle component. If used, these affected products could cause delays or prolonged procedures, or particulate material could enter the bloodstream and potentially result in pulmonary embolism or ischemia.
The recall affects multiple lot numbers spanning from lot 9665716 through lot NS988039. The source document does not specify a remedy for consumers who have obtained affected products.
Written by software from the official notice below. Not reviewed by a lawyer.
The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.
Reason for recall: The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia. Distribution: US Nationwide. Brazil, Canada, Quantity: 11,451 units Lot/code info: UDI-DI: (01)00827002028388; Lot Numbers: 9665716, 9679942, 9686540, 9686549, 9689250, 9689343, 9692548, 9692549, 9699716, 9699717, 9705738, 9709183, 9712150, 9712373, 9736455, 9742510, 9746575, 9746716, 9760404, 9760475, 9766121, 9775119, 9780326, 9782923, 9785433, 9792467, 9793490, 9799632, 9799638, 9804929, 9824019, 9826828, 9826829, 9829654, 9830524, 9836105, 9836209, 9871734, 9873996, 9889391, 9892371, 9895593, 9898132, 9898730, 9902290, 9902927, 9910485, 9916495, 9916503, 9924121, 9931357, 9931541, 9938186, 9938235, 9946241, 9952626, 9952627, 9952726, 9954044, 9954213, 9961061, 9969348, 9975178, 9976722, 9978990, 9880405, 9981888, 9999793, 9999803, 10003519, 10005927, 10009215, 10009245, 10024184, 10024217, 10024218, 10032460, 10035628, 10035750, 10044472, 10044906, 10051940, 10055076, 10108943, 10109034, 10111785, 10117980, 10121837, 10121846, 10127381, 10127456, 10130377, 10130378, 10133950, 10133956, 10133957, 10133961, 10134000, 10142279, 10145130, 10148417, 10148426, 10148473, 10148591, 10148632, 10161897, 10161961, 10164500, 10164506, 10169956, 10169957, 10190606, 10190623, 10190633, 10190677, 10195251, 10197815, 10197831, 10200912, 10200913, 10207095, 10209858, 10220200, 10220208, 10222904, 10222926, 10226192, 10229970, 10229997, 10229998, 10236738, 10243510, 10243516, 10245424, 10247563, 10251181, 10266211, 10269457, 10327125, 10327126, 10327131, 10327133, 10327134, 10327136, 10328195, 10328201, 10328210, 10331628, 13004566, 13018910, 9874017X, 9875796X, NS988039
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.