FDA Device recall Z-2649-2020
Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
- FDA Device
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine by Carefusion 2200, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2649-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-28 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carefusion 2200 |
| Distribution | 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 |
Product
Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
Reason
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.
Identifiers
| code_info | Catalog: PIG1260TCDF UDI: 50885403231894; Batches 0001335833 and 0001341627 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2649-2020%22
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