Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0195-2007

Lysus Transport Stand (infusion stand), part number 4896-003

EKOS Corporation / initiated 2006-10-12 / Terminated / root cause: labeling and UDI

Ekos Corp began a recall of Lysus Transport Stand (infusion stand), part number 4896-003 on . The reason FDA records is "Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0195-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
EKOS Corporation
Product
Lysus Transport Stand (infusion stand), part number 4896-003
Product code
FDX Endoscopic Cytology Brush
Reason for recall
Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
The firm''s representatives will visit the consignees, apply the caution label and provide a letter, dated October 2, 2006, to the consignee. The letter states that the representative applied the caution label to the cart and reminds consignees if the UPS is removed and the cart is loaded with pumps and bags there is a potential for the cart to tip.
Quantity in commerce
84 carts
Distribution
Nationwide.
Product codes and lots
060113010-001, 060113010-002, 060113010-003, 060113010-004, 060113010-005, 060113010-006,  060113010-007, 060113010-008, 060113010-009,  060113010-010, 060113010-011, 060113010-012, 060113010-013, 060113010-014, 060113010-015,  060324025-001, 060324025-002  The additional carts do not contain any type of serial number.