The Recall Desk
HighFDA (Devices)·Z-2529-2021·Announced 2021-09-29

Foley Catheter Tray Recalled Due to Potential Packaging Defects

C.R. Bard is recalling 2,660 units of SureStep Foley Catheter Trays nationwide due to potential packaging defects that may impact the sterile barrier.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a medical device with the potential to compromise sterility and safety. Although no injuries or illnesses have been reported, a compromised sterile barrier on a catheter represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

C.R. Bard Inc. is recalling 2,660 units of the SureStep Foley Tray with Bard Lubricath Foley Catheter (Catalog A800061, Lot NGFR3658) due to potential packaging defects that may impact the sterile barrier.

The affected units have been distributed nationwide. If you have received this product, contact C.R. Bard Inc. or your healthcare provider for instructions.

The recalled product

Product
Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Manufacturer
C.R. Bard Inc
Category
Medical Device — Catheter / Insertion Tray
Hazard
  • packaging-defect
  • sterile-barrier-defect

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 (3)

  • Catalog A800061
  • Lot NGFR3658
  • UDI (01)00801741104848(17)251228(10)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category