Recall Z-2637-2018 ยท FMG Stopcock, I.V. Set
ICU Medical, Inc.
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.
| Date | Jul 31, 2017 |
| Status | Terminated |
| Reason | Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. |
| Root cause | Labeling mix-ups |
| Action | 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 throug |
| Quantity | 160,016 units total |
| Distribution | 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. |
| FDA record | Open on fda.gov |