—#26339

Product

Sterile Dressing Change Tray with CloraPrep - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 28 trays per case

FDA product code: MCY — Wound Dressing Kit
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: reorder #DYND75221, lot 02KA0269

Why it was recalled

Some of the kits labeled as latex free contain latex gloves which are properly labeled.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: One Medline Place, Mundelein, Illinois 60060

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2003-02-12
Posted by FDA: 2003-03-12
Terminated: 2003-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26339. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.