Class 2 Device Recall Kendall

• Date Initiated by Firm: October 08, 2004
• Date Posted: November 02, 2004
• Recall Status: Terminated on May 15, 2012
• Recall Number: Z-0079-05
• Recall Event ID: 30196
• 510(K)Number: k012736
• Product Classification: Needle, Hypodermic, Single Lumen - Product Code FMI
• Product: Kendall MONOJECT MAGELLAN SAFETY NEEDLE 23G X 5/8 inch; Product Number: 8881850358
• Code Information: Lot numbers in the range of 406100 through 424600 (inclusive)
• Recalling Firm/ Manufacturer: Kendall Healthcare Products Co; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: James Welsh; 508-261-8532
• Manufacturer Reason for Recall: Needle cannula may separate from the hub during use
• FDA Determined Cause: Other
• Action: Recall letters requesting product return were mailed to all customers on October 8, 2004
• Distribution: Nationwide
• 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 = FMI and Original Applicant = TYCO HEALTHCARE