Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine — Class II medical device recall Z-2649-2020
Terminated recall by Carefusion 2200 Inc, reported 2020-07-29, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction
| Recall number | Z-2649-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 2200 Inc, Vernon Hills, IL, United States |
| Recall initiated | 2020-05-28 |
| Classified | 2020-07-18 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2024-09-20 |
| Distributed | AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 50885403231894 |
| Lot numbers | 0001335833, 0001341627 |
| Model numbers | PIG1260TCDF |
Product
Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
Reason for recall
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
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-2649-2020. 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.