—#167075

Product

ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 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: lots: 85-540-SJ, 86-189-SL, 86-911-SJ

Why it was recalled

Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.

Root cause (FDA determination)

Device Design

Action the firm took

On 08/20/18, the firm, icumedical, mailed "URGENT MEDICAL DEVICE RECALL" l notices to consignees. The notice described the product, problem and actions to be taken. If product has been further distributed, the firm requested consignees to notify users. Customers were advised to return affected product only if the blood filter is needed. Customers needing response forms and/or return labels were advised to call 1-800-479-0551. For further inquiries call: 1-866-829-9025.

Recalling firm

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

Distribution

Distribution pattern: U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.

Timeline

Recall initiated: 2018-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167075. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.