Z-1587-2021 Class II Ongoing
FDA device recall Z-1587-2021 was initiated by ICU Medical, Inc. on March 16, 2021 and is designated Class II. Reason for recall: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- March 16, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: 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).
Reason for Recall
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.
Code Information
REF: CH3034 UDI: (01) 1 0840619 02411 3 (17) 260101 (30) 50 (10) 5125305 Lot Number: 5125305