Pressure Monitoring Set — Class II medical device recall Z-1362-2022
Completed recall by Cook Incorporated, reported 2022-07-20, distributed nationwide. The products may contain excess coating material on the outside and/or interior of the needle component. Poten
| Recall number | Z-1362-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2022-05-25 |
| Classified | 2022-07-08 |
| Reported by FDA | 2022-07-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA |
| Quantity | 11,451 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00827002028388 |
| Lot numbers | 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 and 113 more |
Product
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1362-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.