Z-1573-2020 Class II Terminated
FDA device recall Z-1573-2020 was initiated by Bard Peripheral Vascular Inc on October 1, 2019 and is designated Class II. Reason for recall: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This … The recall status is terminated (terminated February 18, 2022). Affected quantity: 598 Catheters.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- October 1, 2019
- Termination Date
- February 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 598 Catheters
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,VA, VT, WA, WI, WV, WY and countries of Brazil, Canada, EMEA, Korea, Mexico, New Zealand.