—#165463

Product

80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K964435, K983559
Affected lot / code info: Item Number Z0878, Lot Number 69-333-SJ, 69-703-SJ, 70-417-SL, 70-939-SJ, 71-366-Y1, 71-898-Y1, 72-280-HE

Why it was recalled

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

The firm, ICUmedical, notified their customers of the recall on about 07/31/2017 via"URGENT: Medical Device Recall Notification letter". Instructions included to inspect inventory on hand for affected devices, remove and return any affected devices, and complete and return the Recall Response Form to ICU Medical RecallCoordinator; email:.Recall@icumed.com; including labeling "Incorrect labeling" in subject or FAX: (801) 264-1755. Instructions also included to notify customers of the recall if devices were further distributed. Questions can be directed to ICU Customer Service Monday through Friday, 7 AM CST - 4:30 PM CT at 877-946-7747, option 9 or e-mail at ProductReturns@icumed.com

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

Timeline

Recall initiated: 2017-07-31
Terminated: 2019-03-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165463. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.