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
Reported: June 14, 2023 Initiated: April 20, 2023 #Z-1701-2023
Product Description
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
Reason for Recall
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Details
- Recalling Firm
- C.R. Bard Inc
- Units Affected
- 308520 devices
- Distribution
- Worldwide
- Location
- Covington, GA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by C.R. Bard Inc. Units affected: 308520 devices.
Why was this product recalled? ▼
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2023. Severity: Moderate. Recall number: Z-1701-2023.
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