The Recall Desk
HighFDA (Devices)·Z-2523-2021·Announced 2021-09-29

C.R. Bard Foley Tray and Drainage Bag Recalled for Packaging Defects

C.R. Bard is recalling 11,780 Foley Tray units 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 recall for a medical device where packaging defects could compromise the sterile barrier. This qualifies as a risk-of-harm product where no injuries have been reported, warranting Score 3 (High) per the rubric.

Plain-English summary

C.R. Bard Inc is recalling Catalog A300316A SureStep Foley Tray kits containing Bardex I.C. drainage bags and StatLock stabilization devices. The recall affects 11,780 units distributed nationwide.

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

Healthcare facilities and patients with these units should verify the lot numbers (NGEVX104 with expiration 08/31/2022; NGFR3628, GFS1114, and NGFS1166 all with expiration 02/28/2023) and contact C.R. Bard for further guidance.

The recalled product

Product
Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Manufacturer
C.R. Bard Inc
Category
Medical Device — Urinary Catheter / Drainage System
Hazard
  • sterile-barrier-defect
  • packaging-defect
  • infection-risk

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 (6)

  • Catalog A300316A
  • Lots: NGEVX104 (exp. 08/31/2022)
  • UDI (01)00801741073731(17)201228(10)
  • NGFR3628 (02/28/2023)
  • GFS1114 (02/28/2023)
  • and NGFS1166 (02/28/2023)

Distribution

Distributed nationwide across the United States.

Related recalls

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