C.R. Bard Inc: 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

Is my product affected?

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 place

• UPC 00801741104299

Check against the official notice below — it lists the full affected range.

What happened

C.R. Bard Inc. is recalling 8,392 units of the SureStep Foley Tray System, a medical device intended for draining, collecting, and measuring urine through catheter insertion. The recall was initiated because a white paper-type residue has been found attached to the catheter in affected units. The recalled products were distributed nationwide across 23 states and are identified by Catalog Number A304716A and UDI 00801741104299, spanning seven lot numbers with expiration dates ranging from March 2021 to November 2021.

The recall notice does not specify a remedy or recommended consumer action for those who have obtained or used this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is potential for a white paper-type residue attached to the catheter.

Details from the source

Reason for recall: There is potential for a white paper-type residue attached to the catheter. Distribution: 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. Quantity: 8392 units Lot/code info: 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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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