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.
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 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
- Hazard
- Affected units
- 2,120
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · C.R. Bard Inc
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