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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm August 16, 2013
Date Posted September 10, 2013
Recall Status1 Terminated 3 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/
Covidien LLC
15 Hampshire Street
Mansfield MA 02048-1113
For Additional Information Contact
Manufacturer Reason
for Recall
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
FDA Determined
Cause 2
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 and Original Applicant = TYCO HEALTHCARE