The Recall Desk
HighFDA (Devices)·Z-0666-2022·Announced 2022-03-02

Bard SureStep Intermittent Catheter Tray recalled for potential leak defect

C.R. Bard is recalling 2,120 units of the BARD SURESTEP INTERMITTENT CATHETER TRAY (14Fr) due to a potential leak at the catheter-to-drain-bag connection.

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 Class II FDA recall of a medical device with a potential leak defect at the catheter-to-drain-bag connection. No injuries, illnesses, or deaths have been reported. The defect represents a risk-of-harm scenario without reported incidents, consistent with the High severity criterion.

Plain-English summary

C.R. Bard Inc. is recalling 2,120 units of the BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr (Reference Number INTS14C). The recalled units have serial numbers NGEWX106, NGEWX143, NGFQ0368, and NGEW9106, identified by UDI code (01)00801741183232(17).

The product has the potential to leak from the catheter where it connects to the drain bag. This is a Class II recall issued by the FDA.

The affected product was distributed nationwide to healthcare facilities and patients in Georgia, Maine, New Jersey, Wisconsin, Minnesota, South Dakota, Colorado, North Dakota, Idaho, Illinois, Florida, Louisiana, Maryland, Pennsylvania, Ohio, and Nebraska.

Customers who have received this product should contact C.R. Bard Inc. for further instructions.

The recalled product

Product
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
Manufacturer
C.R. Bard Inc
Category
Medical Device — Urinary Catheter Tray
Hazard
  • leak

Distribution

Distributed nationwide across the United States.

Related recalls

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