Recall Z-2186-2013 ยท NGT Saline, Vascular Access Flush
Covidien LLC
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 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
| Date | Sep 10, 2013 (initiated Aug 16, 2013) |
| Status | Terminated |
| Reason | Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin |
| Root 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 remove |
| Quantity | 330,120 units |
| Distribution | Worldwide Distribution - USA Nationwide and the country of Bermuda |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032438 | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE Tyco Healthcare, Jun 30, 2004 |