Pressure Monitoring Tray — Class II medical device recall Z-2204-2020
Terminated recall by Cook Inc., reported 2020-06-10, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the
| Recall number | Z-2204-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2020-04-30 |
| Classified | 2020-06-02 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2021-03-29 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | MX |
| Quantity | 1,899 |
| Reason classes | device malfunction |
| Lot numbers | 10133951, 10142269, 10145133, 9402033, 9406111, 9782916, 9789983, 9824026, 9829655, 9850622, 9864806, 9874004, 9880413, 9904717, 9910200, 9922162, 9934864, 9954321, 9961179 |
Product
Pressure Monitoring Tray, C-PMSY, G02854
Reason for recall
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
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-2204-2020. 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.