FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; Medline Industries, Inc., Mundelein, IL 60060-4486
- Recall number
- Z-0268-2007
- Recalling firm
- Medline Industries Inc
- Product
- Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; Medline Industries, Inc., Mundelein, IL 60060-4486
- Status
- Terminated
- Initiated
- 2006-11-21
- Posted
- 2006-12-14
- Terminated
- 2008-01-31
- Reason
- The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
- Root cause
- Other
- Action
- On 11/21/06, Medline telephoned the accounts who may have received the recalled lots, informing them that the skin scrub trays may not have gone through the full manufacturing cycle and are not sterile. They were requested to check their inventories for the two affected lots, removing any found from inventory and placing it on hold for return to Medline. The accounts were then sent a recall letter via fax on the same date, reiterating the telephone calls, and requesting the accounts to complete and fax back the attached response form, indicating amount of each lot placed on hold. Any questions were directed to Medline''s recall hotline at 866-359-1704.
- Quantity
- 47 cases
- Distribution
- Minnesota, Illinois, Wisconsin and Indiana
- Lot, serial or model codes
- Reorder # DYND70660, lots 06JC0016 and 06JC0017, exp. 08-08
- 510(k) numbers
- ["K914174"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1417592
- Firm city
- Mundelein
- Firm state
- IL
- 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