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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. (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 #

118790412

High-Pressure Filter PRIMARY I.V. PLUMSET Convertible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK

855505H, 865135H, 918695H, 928085H, 937325H, 3864774, 3935434, 4011065, 4088425

142560488

Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch

865455H, 896215H, 897455H, 3864785, 4095291

149530489

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

925155H

 

Item Code

Product Description - Sapphire Sets

Lot #

163350455

SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch

855935H, 855965H, 876145H, 885395H, 896135H, 936605H, 3843263, 3864786

163620455

SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch

855645H, 885415H, 896625H, 4008547

163630455

SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch

876175H, 885385H, 896995H, 908235H, 925755H, 3843264

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.

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 

 

Cision

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