Recall Z-2185-2013— Covidien LLC

Name: FDA recall Z-2185-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-16

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2013-08-16, terminated 2015-10-21. It names one FDA 510(k) clearance: K032438. Product: Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 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. Reason: Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin.

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2013-08-16
Terminated: 2015-10-21
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K032438 — MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGETyco Healthcare·cleared 2004-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.