Z-1970-2020 Class II Terminated
FDA device recall Z-1970-2020 was initiated by C.R. Bard Inc on April 15, 2020 and is designated Class II. Reason for recall: There is potential for a white paper-type residue attached to the catheter. The recall status is terminated (terminated May 20, 2021). Affected quantity: 8392 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- April 15, 2020
- Termination Date
- May 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8392 units
Product Description
SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Reason for Recall
There is potential for a white paper-type residue attached to the catheter.
Distribution Pattern
US Nationwide distribution including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV.
Code Information
Catalog Number: A304716A UDI: 00801741104299 Lot Numbers: NGDX4745 (Exp. 03/20/2021); NGDY0567 (Exp. 03/20/2021); NGDW1548 (Exp. 11/30/2021); NGDW0234 (Exp. 11/30/2021); NGDX4088 (Exp. 11/30/2021); NGDX4704 (Exp. 11/30/2021); NGDY0568 (Exp. 11/30/2021)