Class 2 Device Recall Kendall/Tyco Monoject

• Date Initiated by Firm: March 28, 2008
• Date Posted: May 09, 2008
• Recall Status: Terminated on June 25, 2012
• Recall Number: Z-1600-2008
• Recall Event ID: 47436
• 510(K)Number: K032438
• Product Classification: Heparin Access Flush - Product Code NZW
• Product: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL REF # 8881590123, Tyco Healthcare, Mansfield, MA 02048
• Code Information: Lot Numbers: 7041194; 7072154; 7113034; 8010194
• Recalling Firm/ Manufacturer: Covidien LP; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: SAME; 508-261-8000
• Manufacturer Reason for Recall: Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
• FDA Determined Cause: Material/Component Contamination
• Action: Tyco Healthcar notifed customers by letter sent via US Postal Service beginning 3/28/08, through 4/1/08. The letter requests that they immediately stop using and return the product. Distributors are requested to in-turn notify their customers. An instruction sheet was attached for product return and replacement. All customers are required to respond to the notice regardless of remaining inventory. .
• Quantity in Commerce: 1,138,860 units
• Distribution: Nationwide Distribution
• 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 = NZW