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Class 2 Device Recall IV Adminstration Sets with ChemLock Ports |
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Date Initiated by Firm |
February 25, 2016 |
Create Date |
October 11, 2018 |
Recall Status1 |
Terminated 3 on August 26, 2016 |
Recall Number |
Z-1259-2016 |
Recall Event ID |
73391 |
510(K)Number |
K131549
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Product Classification |
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System - Product Code ONB
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Product |
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids. |
Code Information |
2775926 2812305 2817810 2822507 2869949 2906006 2935267 2956661 3000036 3021000 3022814 3050749 3093071 3106072 3112028 3113234 3116570 3122924 3124606 3128409 3146957 3154612 3158607 3160103 3172391 3179951 3182579 |
Recalling Firm/ Manufacturer |
ICU Medical, Inc. 951 Calle Amanecer San Clemente CA 92673-6212
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For Additional Information Contact |
949-366-2183
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Manufacturer Reason for Recall |
ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
A customer notification letter dated 2/25/16 was sent to all customers who purchased the IV Administration Sets with ChemoLock Port to inform them that ICU Medical has identified an issue with a connection in an isolated number of I.V. Infusion administration sets that incorporate the ChemoLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak. Customers are informed of the actions to be taken. Customers are instructed to return and complete the recall response form to ICU Medical via Fax (801) 264-1755 or by email: recall@icumed.com. Customers with questions or require assistance relating to the recall are instructed to contact Customer Service Monday through Friday between the hours of 8:30AM-4:00PM Pacific Time, (866) 829-9025 and select option 8, or email at customerservice@icumed.com. |
Quantity in Commerce |
7,500 units |
Distribution |
US: NV, OH, MO, CA, FL, VA, TX, NJ, CT, MI, AZ, MA, CO
Non-US: DE, AE, AT, PL, HU, SE, IL, JP, JO, SA, |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = ONB and Original Applicant = ICU MEDICAL INC
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