Business
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
About this update from Icu Medical, Inc.
[{"type":"text","content":"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.\nBased on complaints the affected product lots, which were distributed nationwide to ICU Medical customers, are listed below:\n \nICU 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.\nCustomers 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. \nIf 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.\nAs 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.\nComplete 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-0178This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.\nAdditional information regarding this recall, along with notifications to the customer can be found on ICU Medical's Website here.\nMedia Contact:\nTo...