FDA Device recall Z-0271-2018
Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads
- FDA Device
- Class II
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class II recall of Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads by C R Bard, citing hydrogel peeling from the pads.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0271-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-16 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | C R Bard |
| Distribution | CA, FL, IL, LA, MN, MO, NY, OK, TN, TX |
Product
Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.¿
Reason
Hydrogel peeling from the pads.
Identifiers
| code_info | Product Code: 31705 Lot # NGBS1063 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by C R Bard
- Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741…
FDA Device · Class II · 2026-09-16 · C R Bard - Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 108017411…
FDA Device · Class II · 2026-09-16 · C R Bard - Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes:…
FDA Device · Class II · 2026-09-16 · C R Bard - Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 0…
FDA Device · Class II · 2026-09-16 · C R Bard - Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08…
FDA Device · Class II · 2026-09-16 · C R Bard
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0271-2018%22
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