The Recall Desk
HighFDA (Devices)·Z-2525-2021·Announced 2021-09-29

C.R. Bard Foley Catheter Tray Recalled for Potential Packaging Defect

C.R. Bard is recalling 11,600 units of its Foley catheter tray assembly nationwide due to potential packaging defects that may compromise 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: FDA Class II medical device recall with potential sterile barrier compromise on an invasive urinary catheter system. No illnesses or injuries reported, but the theoretical hazard poses direct infection risk, meeting criteria for High severity.

Plain-English summary

C.R. Bard Inc. is recalling approximately 11,600 units of its Foley catheter tray assembly (Catalog A303316A), which includes the SureStep Foley Tray, Bardex I.C., Complete Care Urine Meter, and StatLock Stabilization Device. The products were distributed nationwide in the United States.

The recall was initiated because of potential packaging defects that may impact the sterile barrier. A compromised sterile barrier could expose the device to contamination before use, potentially subjecting patients to infection risk when the catheter is inserted.

Healthcare facilities and providers should discontinue use of the affected units and contact C.R. Bard Inc. for information on product replacement or returns. The affected lot numbers are NGEVX103 (expires 08/31/2022), NGFR3290 (expires 02/28/2023), NGFR3291 (expires 02/28/2023), and NGFR4542 (expires 02/28/2023).

The recalled product

Product
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Manufacturer
C.R. Bard Inc
Category
Medical Device — Foley catheter assembly
Hazard
  • sterile-barrier-compromise
  • contamination-risk
  • packaging-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 (7)

  • Catalog A303316A
  • Lots: NGEVX103 (exp. 08/31/2022)
  • UDI (01)00801741073793(17)201220(10)
  • NGFR3290 (02/28/2023)
  • NGFR3291 (exp. 02/28/2023)
  • UDI (01)00801741073793(17)201220(10)
  • and NGFR4542 (exp. 02/28/2023) UDI (01)00801741073793(17)201220(10)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category