Atlas FDA

Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Numbe

FDA device recall Z-2039-2024 · posted 2024-06-07 · Completed

Recall details

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Reason for recall
Quarantined product was inadvertently distributed
Action taken
McKesson 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.
Root cause
Component change control
Status
Completed
Product code
FMF
Quantity affected
5 Boxes (20 per box, 100 eaches)
Distribution
US Nationwide distribution in the state of NJ.
Date initiated
2024-04-23
Date posted
2024-06-07
Location
Richmond, VA

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) (K131641)Nipro Medical Corporation2013-08-28