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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
Recall Reason Description
Potential for small amounts of fluid leaking out of the air vents on the inline filters
- Company Name:
- ICU Medical, Inc.
- Brand Name:
- Product Description:
ICU Medical, Inc. 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
|163830455||SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch||855665H, 865495H, 896195H
|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|
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
- Regular Mail or Fax: 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 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.
Company Contact Information
- 1-866-829-9025 option 8