ClearanceBrief
Recall Z-2039-2024 ยท FMF Syringe, Piston

Mckesson Medical-Surgical Inc. Corporate Office

Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number: 8881560125

DateJun 7, 2024 (initiated Apr 23, 2024)
StatusCompleted
ReasonQuarantined product was inadvertently distributed
Root causeComponent change control
ActionMcKesson notified one consignee by telephone on 4/11/24. Spoke with Nurse and confirmed product was received and confirmed that four (4) boxes were picked up by a McKesson Driver and one (1) box was used.
Quantity5 Boxes (20 per box, 100 eaches)
DistributionUS Nationwide distribution in the state of NJ.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K131641MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
Nipro Medical Corporation, Aug 28, 2013