CLASS II Device recall · Reported 20 Jul 2022 · FDA Enforcement Report
Pressure Monitoring Set, Single-lumen uncoated central recalled
Cook is recalling Pressure Monitoring Set, Single-lumen uncoated central venous catheter, distributed nationwide in the US. The recall was initiated on 25 May 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1362-2022
- FDA event ID
- 90393
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 25 May 2022
- FDA classified
- 8 Jul 2022
- Reported
- 20 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 25 May 2022 | Recall initiated by company | |
| 8 Jul 2022 | Classified by FDA | +44 days |
| 20 Jul 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Where it was distributed
US Nationwide. Brazil, Canada,
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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, NS9880393
Where was it sold?
US Nationwide. Brazil, Canada,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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