FDA Device recall Z-1307-2018
HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch by C R Bard, citing several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1307-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-14 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | C R Bard |
| Distribution | US |
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.
Reason
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Identifiers
| code_info | Item 50610 Lots #'s: JUBT0404, JUBP0700, JUBR2498, JUBS1289 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1307-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.