—#121125

Product

Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 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

FDA product code: NGT — Saline, Vascular Access Flush
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K032438
Affected lot / code info: Lot Numbers: 13A0084N

Why it was recalled

Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Covidien LLC
Address: 15 Hampshire Street, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide and the country of Bermuda

Timeline

Recall initiated: 2013-08-16
Posted by FDA: 2013-09-10
Terminated: 2015-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121125. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.