Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0696-05

Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S

Centurion Medical Products, LP / initiated 2005-03-08 / Terminated / root cause: labeling and UDI

Tri-State Hospital Supply Corp began a recall of Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S on . The reason FDA records is "Some of the needles in these sets are 3/4 inches in length instead of the labeled 1 inch". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0696-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Centurion Medical Products, LP
Product
Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S.
Product code
KZH Introducer, Syringe Needle
Reason for recall
Some of the needles in these sets are 3/4 inches in length instead of the labeled 1 inch.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Consignees were notified via recall letter dated March 8, 2005 and asked to retun any unused product.
Quantity in commerce
1350
Distribution
Alabama, Kentucky, Michigan, Mississippi, Missouri, North Carolina and South Carolina.
Product codes and lots
Lots 11014, 12134 and 01105.