The Recall Desk
HighFDA (Devices)·Z-0667-2022·Announced 2022-03-02

Bard Surestep Intermittent Catheter Tray Recalled for Connection Leaks

C.R. Bard Inc recalled 1,620 units of Bard Surestep Intermittent Catheter Tray because the catheter may leak where it connects to the drain bag. No injuries have been reported.

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 medical device recall for a product defect (leak at catheter connection) that presents a risk of harm through system malfunction or potential contamination, but no injuries or hospitalizations have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.

Plain-English summary

C.R. Bard Inc is recalling 1,620 units of the Bard Surestep Intermittent Catheter Tray, 14Fr (REF INTS16C) due to a potential to leak from the catheter where it connects to the drain bag.

The leak could potentially compromise the function of the catheter system and the integrity of the drainage connection. No injuries or illnesses have been reported in connection with this defect.

The affected products are identified by serial numbers NGEWX117, NGEXX133, NGEY0842, and NGEZ1823. The products were distributed nationwide in Georgia, Maine, New Jersey, Wisconsin, Minnesota, South Dakota, Colorado, North Dakota, Idaho, Illinois, Florida, Louisiana, Maryland, Pennsylvania, Ohio, and Nebraska.

Patients and healthcare providers who have received or distributed these products should contact C.R. Bard Inc for further information regarding replacement or return of the affected units.

The recalled product

Product
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Manufacturer
C.R. Bard Inc
Category
Medical Device — Catheter
Hazard
  • leak
  • catheter-defect

Distribution

Distributed nationwide across the United States.

Related recalls

Same category