The Recall Desk
HighFDA (Devices)·Z-2540-2021·Announced 2021-09-29

C.R. Bard Foley Catheter Care Kits Recalled for Potential Sterile Barrier Defect

C.R. Bard Inc is recalling Foley catheter care kits (catalog A303416A) because potential packaging defects could compromise the sterile barrier. Approximately 6,440 units were 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 potential risk-of-harm medical device where no illnesses or injuries have been reported. The sterile barrier defect is a theoretical hazard that could result in product contamination, warranting a High severity rating per FDA Class II guidelines without confirmed adverse events.

Plain-English summary

C.R. Bard Inc is recalling certain Foley catheter care kits due to potential packaging defects that may compromise the sterile barrier. The affected product is catalog number A303416A (SureStep Foley Tray, Lubri-Sil I.C., Temperature Sensing Complete Care Drainage Bag, StatLock Stabilization Device), with lot numbers NGFS1844 and NGFS1845.

Approximately 6,440 units of this product were distributed nationwide throughout the United States. A packaging defect has the potential to affect the sterile barrier integrity of the product.

The recalled product

Product
Catalog A303416A, 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 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 (4)

  • Catalog A303416A
  • Lot NGFS1844
  • UDI (01)00801741073823(17)201228(10)
  • NGFS1845

Distribution

Distributed nationwide across the United States.

Related recalls

Same category