The Recall Desk
HighFDA (Devices)·Z-2538-2021·Announced 2021-09-29

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

C.R. Bard is recalling a Foley catheter tray system due to packaging defects that may compromise the sterile barrier. The recall affects 8,170 units 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: This is a Class II medical device recall. The hazard is potential packaging defects affecting the sterile barrier, which presents a risk-of-harm scenario. No adverse events or illnesses are mentioned in the recall notice.

Plain-English summary

C.R. Bard Inc. is recalling Catalog A319516AM SureStep Foley Tray kits, which include lubricant, temperature sensing drainage bags, and stabilization devices. Affected lot numbers include NGFS1691, NGFR3282, and NGFR4423.

The recall was initiated due to potential packaging defects that may impact the sterile barrier of the products.

The recalled products were distributed nationwide in the United States. Healthcare facilities and patients who have received this product should contact C.R. Bard for instructions on return or replacement.

If you have questions or concerns, contact C.R. Bard or your healthcare provider.

The recalled product

Product
Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
Manufacturer
C.R. Bard Inc
Category
Medical Device — Urinary Catheter Kit
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 (5)

  • Catalog A319516AM
  • Lot NGFS1691
  • UDI (01)00801741073892(17)201228(10)
  • NGFR3282
  • and NGFR4423

Distribution

Distributed nationwide across the United States.

Related recalls

Same category