Z-1701-2023Class II

HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF...

Name: Z-1701-2023 HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF...
Creator: C.R. Bard Inc
Published: 2023-04-20
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2023-04-20 / Open, Classified / root cause: labeling and UDI

FDA source

C.R. Bard Inc began a recall of 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 on 2023-04-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1701-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-20
Posted: 2023-06-08
Recalling firm: C.R. Bard Inc
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
Product code: EZD Catheter, Straight
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by 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
Quantity in commerce: 308520 devices
Distribution: Worldwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1701-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1698-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-08
Z-1699-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-08
Z-1700-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-08
Z-1701-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-08

Product code EZD

K150345Class IIMagic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. / cleared 2015-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)