Z-2648-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2020
- Initiation Date
- May 28, 2020
- Termination Date
- September 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Safe-T-Centesis 6 Fr Catheter Drainage Tray
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 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.
Code Information
Catalog: PIG1260T; UDI: 50885403108363; Batches: 0001319266, 0001320359, 0001320361, 0001321495, 0001321903, 0001322646, 0001323766, 0001324093, 0001324318, 0001331342, 0001332814, 0001332817, 0001333972, 0001335443, 0001335444, 0001335695, 0001336580, 0001336581, 0001336582, 0001336962, 0001336963, 0001337307, 0001337983, 0001338432, 0001338452, 0001339413, 0001339782, 0001339783, 0001341546, 0001342258, 0001342587, 0001343637, 0001343638, 0001344743, 0001346287, 0001346479, 0001346480