Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IV Administration Set

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall IV Administration Set see related information
Date Initiated by Firm July 06, 2020
Create Date October 22, 2020
Recall Status1 Terminated 3 on May 11, 2023
Recall Number Z-0187-2021
Recall Event ID 86054
510(K)Number K964435  
Product Classification Set, administration, intravascular - Product Code FPA
Product 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051055(17)250101(30)50(10)4590834;
(01)10887709051055(17)250101(30)50(10)4557481;
(01)10887709051055(17)241201(30)50(10)4536601;
(01)10887709051055(17)250201(30)50(10)4724818;
(01)10887709051055(17)250201(30)50(10)4733548.

The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).




Code Information Lot Numbers:4590834, 4557481, 4536601, 4724818, 4733548.     
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact
844-654-7780
Manufacturer Reason
for Recall		 Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
FDA Determined
Cause 2		 Process control
Action On July 6, 2020, the firm, icumedical, sent an "URGENT: MEDICAL DEVICE RECALL" notification of the market action to direct and indirect consignees of record via UPS. Stericycle, Inc. was contracted to send letters to consignees. The following is included in the "Required Actions for Users" section of the medical device recall notification: 1) Discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) Return affected product using the return label provided with the letter. Call 1-866-203-5570 (M¿ F, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Please do not reproduce. Visit http://expertezlabel.com to request additional labels for returning affected product. To ensure proper and timely credit, follow the instructions on the return label for returning product. Upon receipt of the completed response form and return of the affected product, you will be credited for any product returned. You will only receive credit for product that you return. NOTE: Credits for product purchased through distributor will be credited by the distributor. 4) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product I Table 1 sections of this notification and ask them to call 1-866-203-5570 (M-F, 8am-5pm ET) to obtain a response form. Follow up Actions: Contact Customer Service using the information provided below for assistance reordering replacement product and for further inquiries: Global Complaint Management -1-844-654-7780 or ProductCompla
Quantity in Commerce Total of all products (Listed #1 thru 101) = 304735 units
Distribution Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = ICU MEDICAL, INC.
-
-