—#161289

Product

5" (13 cm) Smallbore Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. 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: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K964435
Affected lot / code info: Lot number 3549002, UDI 01) 0 0887709 01857 0 (17) 221001 (30) 01 (10) 3549002.

Why it was recalled

The infusion sets were manufactured with an incorrect spin collar.

Root cause (FDA determination)

Process control

Action the firm took

The firm, ICU Medical Inc., sent an "URGENT: Medical Device Recall Notification" letter dated 2/5/2018 to its customers via UPS on 2/5/2018 in the U.S. The letter described the product, problem and actions to be taken. The customers were instructed to: inspect your inventory for specific product and lot numbers; quarantine all affected devices; complete and return the Recall Response Form as applicable (even if you have no affected devices) via Fax to: 1-866-899-7474 or email to: ICUMedical2805@stericycle.com; if you have distributed the product further, notify your accounts that received the product and ask them to contact Stericycle at 1-866-629-6182 (M-F, 8am-5pm ET) to receive a Response Form. Return affected product to Stericycle using labels provided, if you have not received a return label or reply form or require additional assistance, please contact Stericycle at 1-866-629-6182 (M-F, 8am-5pm) the return labels are for single use only. For additional labels visit http://expertezlabel.com. For further inquiries, please contact ICU Medical Inc. for Global Complaint Management at ProductComplaintsPP@icumed.com or ICU Customer Service at 1-866-829-9025, option 2 (M-F, 8:30am-4pm PT).

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.

Timeline

Recall initiated: 2018-02-05
Terminated: 2019-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.