Class 2 Device Recall Covidien

• Date Initiated by Firm: August 16, 2013
• Date Posted: September 10, 2013
• Recall Status: Terminated on October 21, 2015
• Recall Number: Z-2178-2013
• Recall Event ID: 65978
• 510(K)Number: K032438
• Product Classification: Saline, vascular access flush - Product Code NGT
• Product: Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices
• Code Information: Lot Numbers: 13A0084N 13A0094 13B0364 13C0514
• Recalling Firm/ Manufacturer: Covidien LLC; 15 Hampshire Street; Mansfield MA 02048-1113
• For Additional Information Contact: 508-261-8000
• Manufacturer Reason for Recall: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
• FDA Determined Cause: Process control
• Action: Covidien sent an Urgent Medical Device Recall letter dated August 16, 2013 via Federal Express to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested that customers immediately quarantine and discontinue use of the affected products, return any affected product by following the instructions provided in the letter, and complete and return the Recalled Product Return Form to Covidien. The letter states that if the affected products have been distributed, assure that all customers are notified and affected product is removed from the distribution channel as well as from customer stock. Questions or concerns, please do not hesitate to contact your Covidien representative or Covidien Customer Service, Monday through Friday, 8am- 6:30pm ET, at (800) 962-9888, option 1, and then option 2. Firm issued Press on 8/19/13
• Quantity in Commerce: 3,235,860 units
• Distribution: Worldwide Distribution - USA Nationwide and the country of Bermuda
• 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 = NGT