Safe-T-Centesis 6 Fr Catheter Drainage Tray
FDA Recall Z-2648-2020 · Posted None
Recalling FirmCarefusion 2200 Inc
Recall StatusTerminated
Product CodePXI
Date Initiated2020-05-28
Date Terminated2024-09-20
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.
Firm Action
All affected consignees are being notified via FedEx mailed letter and/or email beginning 6/15/2020. BD requests a sub-recall to be conducted if product has been further distributed. Consignees are asked to complete the acknowledgement form included with the notification letter and return to BD.
Root Cause
Under Investigation by firm
Distribution Pattern
370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, 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 Customer listed, including Federal distribution, uploaded.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.