FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Sterile Dressing Change Tray with CloraPrep - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 28 trays per case
- Recall number
- Z-0645-03
- Recalling firm
- Medline Industries Inc
- Product
- Sterile Dressing Change Tray with CloraPrep - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 28 trays per case
- Status
- Terminated
- Initiated
- 2003-02-12
- Posted
- 2003-03-12
- Terminated
- 2003-08-12
- Reason
- Some of the kits labeled as latex free contain latex gloves which are properly labeled.
- Root cause
- Other
- Action
- Recalled by letter dated 2/11/03. The accounts were informed that some of the suction catheter trays labeled as latex free actually contained latex gloves. The latex glove wrapper has a latex warning on it. The accounts were instructed to return any of the suspect lot of trays to Medline for replacement or credit. The recall was expanded by letterdated 3/3/03 to include the one lot of dressing change trays for the same problem and the same instructions.
- Quantity
- 207 cases
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- reorder #DYND75221, lot 02KA0269
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MCY
- 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