Device product
REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Z-1569-2021
Product summary
- Event
- Event 87703
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1569-2021
Official wording
Reason: 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.
Code information: REF: CH2000S CH2000S-10 CH2000S-C CH2000SC-10 CH2000SC-5 CH2000SC-5 CH2050 UDI: (01) 1 0840619 033900 (17) 260101 (30) 100 (10) 5125299 (01) 1 0840619 03391 7 (17) 260101 (30) 50 (10) 5142922 (01) 1 0840619 02661 2 (17) 260101 (30) 50 (10) 5125303 (01) 1 0840619 04276 6 (17) 260101 (30) 50 (10) 5142969 (01) 1 0887709 07689 8 (17) 260101 (30) 50 (10) 5125289 (01) 1 0887709 07689 8 (17) 260101 (30) 50 (10) 5142945 (01) 1 0887709 12231 1 (17) 260101 (30) 25 (10) 5125288 Lot Number: 5125299 5142922 5125303 5142969 5125289 5142945 5125288
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.
Derived failure modes
-
Unknown
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.