8/21 - Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization P
Wednesday, August 21, 2013
8/21 - Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume And Wrapper
ISSUE: Covidien announced that it has initiated a
voluntary recall of certain lots of Monoject prefill flush syringes. This
recall is being conducted due to the risk that a number of the syringes were
filled with water but not subjected to the autoclave sterilization process.
These products are labeled as either sodium chloride flush or heparin lock
flush. Some of these syringes have the mismatched syringe tip cap, syringe
label, filled volume and wrapper. However, for the sodium chloride flush
syringes with matched tip cap, syringe label, filled volume and wrapper, there
are no visual cues for the clinician to identify the problematic products. If
non-sterile fluid is administered there is a health risk of life-threatening
infection to the blood stream or other areas. Also if the clinician uses the
heparin lock flush syringe containing only water on peripheral or venous
catheters, the patency of the intravascular device may not be maintained and
clotting may occur. This could result in non-functional intravenous access
requiring the device to be replaced.
BACKGROUND: Only Monoject prefill flush syringes from
the lot numbers listed are affected by this action (see Firm Press Release for
list of affected lot numbers). The lot numbers can be found on the shipper
case, carton and individual syringes. Customers are required to identify,
segregate and return any affected products in their inventory.
RECOMMENDATION: Customers have been notified of this issue
by letter dated August 16, 2013. To return the affected product for credit,
please contact our Customer Service group at 1-800-962-9888.
Healthcare professionals and patients are encouraged to
report adverse events or side effects related to the use of these products to
the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to
Read the complete MedWatch Safety Alert, including a link
to the Press Release, HERE.