Z-1574-2020 Class II Terminated

Recalled by Bard Peripheral Vascular Inc — Tempe, AZ

FDA device recall Z-1574-2020 was initiated by Bard Peripheral Vascular Inc on Oct 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 Feb 18, 2022). Affected quantity: 650 Catheters.

Recall Details

Product Type
Devices
Report Date
Apr 1, 2020
Initiation Date
Oct 1, 2019
Termination Date
Feb 18, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
650 Catheters

Product Description

1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587

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 can result in a prolongation of operation.

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.

Code Information

7726950 Lot # RECQ1106, RECR2195 7726954 Lot # RECU1837

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1574-2020
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.