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.
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 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
- Affected units
- 1,620
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
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