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Open, Classified

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

FDA Recall Z-1701-2023 · Posted 2023-06-08

Recalling FirmC.R. Bard Inc
Recall StatusOpen, Classified
Product CodeEZD
Date Initiated2023-04-20
Product Quantity308520 devices

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.

Firm Action

The firm issued an URGENT MEDICAL DEVICE RECALL to its consignee beginning on 04/20/2023 by Fed Ex and email. The notice explained the problem, risk, and requested the following actions be taken: Discontinue distribution of the product and dispose of all affected product, Distributors are directed to notify their customers. For further assistance please contact: 1-844-8BD- LIFE (1-844-823-5433) Say "Recall" when prompted; M-F 8am - 5pm CT

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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