CLASS II Device recall · Reported 18 Sep 2013 · FDA Enforcement Report
Monoject/mL Heparin Lock Flush Syringe with Fill Product ID recalled
Covidien is recalling Monoject/mL Heparin Lock Flush Syringe with Fill Product ID: 8881580125, distributed nationwide in the US. The recall was initiated on 16 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2183-2013
- FDA event ID
- 65978
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Aug 2013
- FDA classified
- 10 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Infusion Pumps
Timeline
| 16 Aug 2013 | Recall initiated by company | |
| 10 Sep 2013 | Classified by FDA | +25 days |
| 18 Sep 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - USA Nationwide and the country of Bermuda
Questions about this recall
Is Monoject/mL Heparin Lock Flush Syringe with Fill Product ID: 8881580125 recalled?
Yes. Covidien recalled Monoject/mL Heparin Lock Flush Syringe with Fill Product ID: 8881580125 on 16 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2183-2013.
Why was it recalled?
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Which lots are affected?
Lot Numbers: 13A0084N
Where was it sold?
Worldwide Distribution - USA Nationwide and the country of Bermuda
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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