Z-1362-2022Class II

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Name: Z-1362-2022 Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Creator: Cook Incorporated
Published: 2022-05-25
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2022-05-25 / Completed / root cause: manufacturing process

FDA source

Cook Incorporated began a recall of Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838 on 2022-05-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1362-2022
Classification: Class II
Status: Completed
Initiated: 2022-05-25
Posted: 2022-07-08
Recalling firm: Cook Incorporated
Product: Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: URGENT: MEDICAL DEVICE RECALL notification letters dated 5/25/22 were sent to customers. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. Note: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. Action being Taken by Cook Medical Cook Medical is removing devices potentially impacted from the market. An investigation was previously performed for this issue. As a result, actions have been taken to prevent further occurrence of this issue. Lots involved in this recall were manufactured prior to preventative actions. We recognize that this situation is a potential disruption to your normal operations, and we sincerely apologize. Thank you for your immediate assistance in this matter. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. We look forward to your response.
Quantity in commerce: 11,451 units
Distribution: US Nationwide. Brazil, Canada,
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1362-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1362-2022	Class II	Completed	Voluntary: Firm initiated	2022-07-20	2022-07-08

Product code DQY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)