Covidien LLC: Medical Device Recall in 2013 - (Recall #: Z-2178-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 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 Classification:

Class II

Date Initiated: August 16, 2013

Date Posted: September 18, 2013

Recall Number: Z-2178-2013

Event ID: 65978

Reason for Recall:

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

Status: Terminated

Product Quantity: 3,235,860 units

Code Information:

Lot Numbers: 13A0084N 13A0094 13B0364 13C0514

Distribution Pattern:

Worldwide Distribution - USA Nationwide and the country of Bermuda

Voluntary or Mandated:

Voluntary: Firm initiated