FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
- Recall number
- Z-0590-2018
- Recalling firm
- C.R. Bard, Inc.
- Product
- Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
- Status
- Open, Classified
- Initiated
- 2017-06-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.
- Root cause
- Labeling mix-ups
- Action
- Customers were notified on approximately 06/02/2017 via FedEx with delivery confirmation and per the individual country's delivery system. Instructions included to examine inventory and identify any product subject to the recall and notify customers if product was further distributed. If customers wished to return product, they were instructed to contact customer service at 1-800-526-4455.
- Quantity
- 128 units
- Distribution
- Distributed domestically. Distributed internationally to Australia and Belgium.
- Lot, serial or model codes
- Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.
- 510(k) numbers
- ["K142702"]
- PMA numbers
- not on file
- Product code
- DWJ
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28