Sterile Dressing Change Tray with CloraPrep - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 28 trays p
FDA device recall Z-0645-03 · posted 2003-03-12 · Terminated
Recall details
- Recalling firm
- Medline Industries Inc
- Reason for recall
- Some of the kits labeled as latex free contain latex gloves which are properly labeled.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MCY
- Quantity affected
- 207 cases
- Distribution
- Nationwide and Canada
- Date initiated
- 2003-02-12
- Date posted
- 2003-03-12
- Date terminated
- 2003-08-12
- Location
- Mundelein, IL
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