Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads recall
Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium…
Why was Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads recalled?
Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number / lot number a) Intrepid ArcticGel Small Pad Kit, 31705I / NGAXY602 b) Intrepid ArcticGel Medium Pad Kit, 31707I / NGAXY603 c) Intrepid ArcticGel Large Pad Kit, 31709I / NGAXY604 d) Intrepid ArcticGel Universal Pad, 31700I / NGAXY601 e) ArcticGel Universal Pad, 31700 / NGAW3898, NGAW3055, NGAZ3417, NGBP1302, NGBP2293, NGBQ1040 f) ArcticGel Universal Pad, 4-pack, 3170004 / NGAW2916, NGAW3893, NGAZ3735, NGBP2294, NGBQ1021 g) ArcticGel X-Small Pad, 31703 / h) ArcticGel X-Small Pad, 2-pack, 3170302 / NGBP0392, NGBN3519 i) ArcticGel Small Pad Kit, 31705 / NGAW3894, NGAW4510, NGAZ2312, NGAZ3312, NGBN2492, NGBP0513 j) ArcticGel Small Pad Kit, 2-pack, 3170502 / NGAW3900, NGAW3059, NGAY4735, NGAZ0554, NGBP0514, NGBP4515 k) ArcticGel Medium Pad Kit, 31707 / NGBN3536, NGBP0512 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 / NGBN3521 m) ArcticGel Large Pad Kit, 31709 / n) ArcticGel Large Pad Kit, 2-pack, 3170902 / o) ArcticGel Small Universal Pad Kit, 31810 / NGBP1534 p) ArcticGel Small Universal Pad,4-pack, 3180104 / NGBP1533, NGBP2320 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) / NGBP3712 r) ArcticGel Neonatal Pad, 2-pack, 3180202 / NGBP0393
- Product
- Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium…
- Recalling firm
- Bard Medical Division
- Quantity
- 7526 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Argentina, Australia, Canada, Saudi Arabia, South Korea, Singapore, Thailand, and Chile
- Recall date
- May 8, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)