Z-2179-2013Class II

Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123

Name: Z-2179-2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123
Creator: Covidien LLC
Published: 2013-08-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-08-16 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and... on 2013-08-16. FDA classified it as Class II and gives the reason as "Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2179-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-16
Posted: 2013-09-10
Terminated: 2015-10-21
Recalling firm: Medtronic, Inc.
Product: Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 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
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Root cause tag: manufacturing process
FDA 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 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: Unknown
Distribution: Worldwide Distribution - USA Nationwide and the country of Bermuda
Product codes and lots: Lot Numbers: 13A0084N

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2179-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2178-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2179-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2180-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2181-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2182-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2183-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2184-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2185-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10
Z-2186-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10

Product code NGT

K032438Class IIModification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush SyringeTyco Healthcare / cleared 2004-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)