Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
This recall has been terminated (originally issued May 28, 2020).
- Recall Initiated
- May 28, 2020
- Terminated
- September 20, 2024
- Recall Number
- Z-2649-2020
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / Code Info
Catalog: PIG1260TCDF UDI: 50885403231894; Batches 0001335833 and 0001341627
Root Cause
Under Investigation by firm
Action Taken
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.