—#199624

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

FDA product code: EZD — Catheter, Straight
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K150345
Affected lot / code info: 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, JUGU9022

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: C.R. Bard Inc
Address: 8195 Industrial Blvd Ne, Covington, Georgia 30014-1497

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2023-04-20
Posted by FDA: 2023-06-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199624. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.