The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2541-2021·Announced 2021-09-29

C.R. Bard Foley Tray Recalled for Potential Sterile Barrier Packaging Defects

C.R. Bard Inc is recalling Foley Tray kits nationwide due to potential packaging defects that may compromise the sterile barrier. The product was distributed throughout the United States.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 an FDA Class II medical device recall with a potential defect that could compromise sterility. No illnesses or injuries have been reported. The hazard represents a risk-of-harm product where injury has not yet been reported, fitting the criterion for Score 3 under the severity rubric.

Plain-English summary

C.R. Bard Inc is recalling Foley Tray kits (Catalog A942216, Lot NGFS3274) nationwide. Approximately 1,440 units of this urological medical device were distributed throughout the United States. The device is used as part of catheter drainage systems for urinary management.

The recall was initiated due to potential packaging defects that may compromise the sterile barrier. A compromised sterile barrier means the product cannot maintain sterility, which is essential for safe use as a medical device.

The recalled product

Product
Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
Manufacturer
C.R. Bard Inc
Category
Medical Device — Urological Devices
Hazard
Affected units
1,440

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 A942216
  • Lot NGFS3274
  • UDI (01)00801741074110(17)201228(10)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

Related recalls

Same manufacturer · C.R. Bard Inc

See all →

Same hazard · packaging defect

See all →

Similar recalls