Z-1552-2021 Class II Terminated
FDA device recall Z-1552-2021 was initiated by Bard Peripheral Vascular Inc on March 25, 2021 and is designated Class II. Reason for recall: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. The recall status is terminated (terminated April 10, 2023). Affected quantity: 287 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- March 25, 2021
- Termination Date
- April 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 287 units
Product Description
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Reason for Recall
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Distribution Pattern
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV.
Code Information
Code: REEV2356, REEX1383, REEX3996