The Recall Desk
HighFDA (Devices)·Z-2526-2021·Announced 2021-09-29

C.R. Bard Foley Catheter Trays Recalled for Packaging Defects

C.R. Bard is recalling 420 units of Foley catheter care 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 medical device has potential packaging defects affecting the sterile barrier. Compromised sterile barriers on urinary catheter equipment represent a risk-of-harm scenario. No illnesses or injuries have been reported, which per the rubric places this at the High severity level.

Plain-English summary

C.R. Bard Inc is recalling Catalog A303318A SureStep Foley Trays with Bardex I.C. catheters, Complete Care urine meters, and StatLock stabilization devices. The affected lot number is NGEVX105, and 420 units were distributed nationwide.

The recall was initiated due to potential packaging defects that may impact the sterile barrier of these medical devices. Consumers with affected products should contact C.R. Bard for further instructions.

The recalled product

Product
Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Manufacturer
C.R. Bard Inc
Category
Medical Device — Urinary Catheter Care
Hazard
  • packaging-defect
  • sterile-barrier-compromise

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 A303318A
  • Lot NGEVX105
  • UDI (01)00801741073809(17)201220(10)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category