medical Class II Updated 2021-05-19

ICU Medical, Inc. recalls REF Spinning Spiros Closed Male Luer - Product Usage: provi

Recalled 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).


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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