Class 2 Device Recall Medline 8Fr Suction Catheter Kit

• Date Initiated by Firm: February 12, 2003
• Date Posted: March 12, 2003
• Recall Status: Terminated on August 12, 2003
• Recall Number: Z-0644-03
• Recall Event ID: 25572
• 510(K)Number: K822510
• Product Classification: Catheter, Irrigation - Product Code GBX
• Product: Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case
• Code Information: reorder #DYND40978, lot 02IA0387
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries Inc; One Medline Place; Mundelein IL 60060
• For Additional Information Contact: Joe Dunn; 800-950-0128
• Manufacturer Reason for Recall: Some of the kits labeled as latex free contain latex gloves which are properly labeled.
• FDA Determined 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 in Commerce: 753 cases
• Distribution: Nationwide and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GBX