—#182752

Product

13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)10887709085227(17)250101(30)50(10)4589920; (01)10887709085227(17)250101(30)50(10)4572950. 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).

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K964435
Affected lot / code info: Lot Numbers:4572801, 4589920, 4572950.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-07-06
Terminated: 2023-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182752. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.