The Recall Desk
HighFDA (Devices)·Z-2537-2021·Announced 2021-09-29

C.R. Bard Foley Catheter Tray Recall Due to Packaging Defects

C.R. Bard Inc is recalling the SureStep Foley Tray (Lot NGEVX108) due to potential packaging defects that may affect the sterile barrier. The product was distributed nationwide.

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: FDA Class II recall of a risk-of-harm medical device with no reported illnesses or injuries. The hazard—packaging defects potentially compromising the sterile barrier—is theoretical and precautionary.

Plain-English summary

C.R. Bard Inc is recalling the SureStep Foley Tray (Catalog A943216), which includes a Lubricath urine meter and StatLock stabilization device, due to potential packaging defects. The recalled product is Lot NGEVX108.

The identified hazard is potential packaging defects that may compromise the sterile barrier of the product. The sterile barrier is critical for maintaining product safety and integrity.

The product was distributed nationwide in the United States. A total of 40 units are subject to this recall.

The recalled product

Product
Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
Manufacturer
C.R. Bard Inc
Category
Medical Device — Foley Catheter Kit
Hazard
  • sterile-barrier-defect
  • contamination-risk

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 A943216
  • Lot NGEVX108
  • UDI (01)00801741100833(17)201228(10)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category