The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2522-2021·Announced 2021-09-29

Foley Catheter Drainage Tray System Packaging Defect Recall

C.R. Bard Inc is recalling a Foley catheter tray system due to potential packaging defects that may compromise the sterile barrier, affecting 1,760 units distributed nationwide.

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: FDA Class II recall of a medical device used in patient care. The hazard—potential packaging defects affecting the sterile barrier—presents a risk of contamination. No illnesses or injuries have been reported.

Plain-English summary

C.R. Bard Inc is recalling its Catalog A300314A SureStep Foley Tray, Bardex I.C., Complete Care Drainage Bag, and StatLock Stabilization Device due to potential packaging defects that may compromise the sterile barrier.

The recall affects 1,760 units with Lot NGFR3627 distributed throughout the United States. A compromised sterile barrier could allow bacteria or other contaminants to reach a product that is intended to be sterile.

Healthcare facilities and patients who have received these units should stop using them immediately and contact C.R. Bard Inc for instructions on product return or replacement.

The recalled product

Product
Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Manufacturer
C.R. Bard Inc
Category
Medical Device — Urinary Catheter System
Hazard
Affected units
1,760

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 A300314A
  • Lot NGFR3627
  • UDI (01)00801741073724(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