ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of Plum and Sapphire Microbore Infusion Sets with Inline Filters

SAN CLEMENTE, Calif., Oct. 7, 2019 /PRNewswire/ -- ICU Medical, Inc. (Nasdaq: ICUI) announced a voluntary recall on 29 July 2019 of certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for small amounts of fluid leaking out of the air vents on the inline filters. To date, ICU Medical is not aware of adverse events related to this matter and is issuing this notification out of an abundance of caution.

Based on complaints the affected product lots, which were distributed nationwide to ICU Medical customers, are listed below:

                  Item
                   Code             Product Description -PlumSets 
      
              Lot #



                        High-Pressure Filter PRIMARY I.V.           855505H, 865135H, 918695H,
                          PLUMSET Convertible Pin, 104 Inch           928085H, 937325H,
                          with Orange Polyethylene-                   3864774, 3935434,
                          Lined*/Light Resistant Tubing,              4011065, 4088425
                          Prepierced Injection Site and

       118790412         OPTION-LOK

    ---

                        Primary PLUM Set 0.2 Micron                 865455H, 896215H, 897455H,
                          Filter, Prepierced Y-Site,                  3864785, 4095291
                          Polyethylene Lined Light
                          Resistant Tubing, Distal
                          Microbore Tubing, Secure Lock,

       142560488         104 Inch

    ---


       149530489        Primary PLUM Set Yellow Striped
                          Tubing, Distal Microbore Tubing,
                          0.2 Micron Filter, Secure Lock,
                          107 Inch                                
      925155H

    ---

                  Item               Product Description -Sapphire
                   Code               Sets                                        Lot #

    ---


       163350455       SAPPHIRE Primary 1.2 Micron                  855935H, 855965H, 876145H,
                         Filter Set Microbore, 122 Inch               885395H, 896135H,
                                                                      936605H, 3843263, 3864786

    ---


       163620455       SAPPHIRE Primary 0.2 Micron                  855645H, 885415H, 896625H,
                         Filter Set, Microbore, CLAVE                 4008547
                         Y-Site, 118 Inch

    ---


       163630455       SAPPHIRE Epidural Set Yellow-                876175H, 885385H, 896995H,
                         Striped Microbore, 0.2 Micron                908235H, 925755H, 3843264
                         Filter 119 Inch

    ---


       163730455       SAPPHIRE Epidural Set Yellow-
                         Striped Microbore, 0.2 Micron
                         Filter, PAV 123 inch                        896225H, 916845H, 925825H

                                                                   
     948155H

    ---


       163830455       SAPPHIRE Primary 0.2 Micron
                         Filter Set Non-Vented,
                         Microbore, PAV, CLAVE Y-Site,
                         122 Inch                                    855665H, 865495H, 896195H

                                                                               3849197, 4064964

    ---


       163840455       SAPPHIRE Primary 1.2 Micron
                         Filter Set Non-Vented,
                         Microbore, PAV, 123 Inch                    855995H, 865505H, 876185H

    ---


       240100401       SAPPHIRE Epidural Set with
                         NRFit Connector Yellow-
                         Striped Microbore, 0.2 Micron
                         Filter 119 Inch                             897525H, 905915H, 926235H

    ---

ICU Medical is asking customers to quarantine all affected product at your facility and return the affected product to Stericycle for credit. For instructions on returning product or additional assistance, call Stericycle at 1-855-311-5437 Monday through Friday, between the hours of 8 a.m. to 5 p.m. Eastern Time.

Customers with questions regarding this recall can call ICU Medical at 1-866-829-9025 option 8, Monday through Friday, between the hours of 8 a.m. and 6 p.m. Central Time.

If the benefits of a filtered microbore infusion set are greater than the potential risks of a filter leak (as described below), please review the customer notification for additional details regarding actions required by the user.

As of the date of this press release, FDA is actively evaluating the information in an effort to classify this recall. Fluid leakage may potentially cause delay of infusion, medication under-delivery, contamination of the fluid path which is on the patient side of the filter, exposure to hazardous medications, or fluid path air-in-line. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    --  Complete and submit the report Online: www.fda.gov/medwatch/report.htm
    --  Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
        1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Additional information regarding this recall, along with notifications to the customer can be found on ICU Medical's Website here.

Media Contact:

Tom McCall
ICU Medical, Inc.
949-366-4368
tmccall@icumed.com

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SOURCE ICU Medical, Inc.