Z-1307-2018Class II

HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an...

Name: Z-1307-2018 HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an...
Creator: C.R. Bard, Inc.
Published: 2017-09-14
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-09-14 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc. began a recall of HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent... on 2017-09-14. FDA classified it as Class II and gives the reason as "Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1307-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-14
Posted: 2018-04-04
Terminated: 2019-11-05
Recalling firm: C.R. Bard Inc
Product: HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
Product code: EZD Catheter, Straight
Reason for recall: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A notification letter was sent to four hundred and fourteen (414) consignees via Federal Express on September 15, 2017. The letter explained the problem and requested return of the product. Distributors were directed to cease distribution of the recalled products and notify their customers of the recall.
Quantity in commerce: 44640.0 units
Distribution: US Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, HI, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Puerto Rico
Product codes and lots: Item 50610 Lots #'s: JUBT0404, JUBP0700, JUBR2498, JUBS1289

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1307-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1307-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-04
Z-1308-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-04
Z-1309-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-04

Product code EZD

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)