HydroSil Go Catheters Recalled for Packaging Sterility Risk
C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters because the resealing label may separate from the foil pouch, potentially compromising product sterility. The recall affects 308,520 devices worldwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall. The hazard is precautionary—a manufacturing defect that could compromise product sterility through packaging separation, without confirmed patient safety impact documented in the recall notice.
Plain-English summary
C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters (Catalog Numbers REF 71808, REF 71810, REF 71812, REF 71814, REF 71816, and REF 71818) distributed worldwide. The recall encompasses 308,520 devices across multiple lot numbers.
The recalled catheters contain a manufacturing defect in which the clear resealing label separates from the product foil pouch. This separation can create an opening in the product packaging that could compromise the catheter's sterility.
Consumers and healthcare facilities that have received these catheters should check their inventory for the affected catalog and lot numbers. If you have the recalled devices, discontinue use and contact C.R. Bard Inc or your healthcare provider for guidance on obtaining replacement products.
The recalled product
- Product
- HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
- Manufacturer
- C.R. Bard Inc
- Affected units
- 308,520
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 (20)
- a) REF 71808
- Lot Numbers: JUGU9026
- b) REF 71810
- Lot Numbers: JUGT9154
- JUGU9053
- JUGV9130
- JUGV9133
- c) REF 71812
- Lot Numbers: JUGT0236
- JUGT1689
- JUGT2702
- JUGU1955
- JUGU1968
- JUGV9158
- d) REF 71814
- Lot Numbers: JUGT3326
- e) REF 71816
- Lot Numbers: JUGU9023
- f) REF 71818
- Lot Numbers: JUGT0288
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
Same manufacturer · C.R. Bard Inc
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- HighC.R. Bard Recalls SureStep Catheter Trays Due to Wipe Contamination
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