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Recall Observatory FDA recall evidence

Device product

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.

Z-1970-2020

April 15, 2020

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 85585
Status
Terminated
Classification
Class II
Quantity
8392 units
Official record key
device-enforcement:Z-1970-2020

Official wording

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

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)

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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