The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-2333-2016·Announced 2016-08-10

C.R. Bard Recalls SureStep Urine Collection System for Labeling Issues

C.R. Bard is recalling 530 SureStep urine collection systems due to a labeling problem. The recall is voluntary and nationwide.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The reason for recall is a labeling problem, which aligns with the 'Low' severity criteria for documentation or packaging issues.

Plain-English summary

C.R. Bard, Inc. is voluntarily recalling 530 units of the SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization. This product is a urine collection system that includes a STATLOCK Foley Stabilization Device. The recall was initiated on June 29, 2016, due to a labeling problem.

The affected units, identified by Lot Number NGZG1722, were distributed nationwide to California, Florida, Illinois, Iowa, Kentucky, North Carolina, Minnesota, Oregon, Rhode Island, South Dakota, Texas, Utah, and Washington. The recall was classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recall status is terminated as of December 5, 2017. Consumers and healthcare providers should check their inventory for this specific lot number and contact C.R. Bard for further instructions regarding the labeling issue.

The recalled product

Product
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Urine Collection System
Hazard
Affected units
530

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number NGZG1722

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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