Recall Z-2183-2013
Covidien LLC · initiated August 16, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 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
Codes / lots: Lot Numbers: 13A0084N
Reason for recall
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
FDA-determined cause: Process control
Action taken
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
Details
- Recall number
- Z-2183-2013
- Initiated
- August 16, 2013
- Posted by FDA
- September 10, 2013
- Terminated
- October 21, 2015
- Product code
- NGT – Saline, Vascular Access Flush
- Quantity
- Unknown
- Distribution
- Worldwide Distribution - USA Nationwide and the country of Bermuda
- Recalling firm
- Covidien LLC, Mansfield, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2178-2013 Class II | Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | 08/16/2013Terminated |
| Z-2179-2013 Class II | Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | 08/16/2013Terminated |
| Z-2180-2013 Class II | Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | 08/16/2013Terminated |
| Z-2181-2013 Class II | Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | 08/16/2013Terminated |
| Z-2182-2013 Class II | Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | 08/16/2013Terminated |
| Z-2184-2013 Class II | Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | 08/16/2013Terminated |
| Z-2185-2013 Class II | Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | 08/16/2013Terminated |
| Z-2186-2013 Class II | Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID:…Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | 08/16/2013Terminated |