Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0885-05

Clinical Technologies, Inc., 25 G Spinal Painpak, Reorder No.:4043, kit manufactured by Integra Spinal...

Spinal Specialties, Inc. / initiated 2005-04-15 / Terminated

Spinal Specialties, Inc began a recall of Clinical Technologies, Inc., 25 G Spinal Painpak, Reorder No.:4043, kit manufactured by Integra Spinal Specialties, San Antonio, Texas on . The reason FDA records is "Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0885-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Spinal Specialties, Inc.
Product
Clinical Technologies, Inc., 25 G Spinal Painpak, Reorder No.:4043, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.
Product code
CAZ Anesthesia Conduction Kit
Reason for recall
Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.
FDA root cause
Other
Action
The firm initiated the recall via letter on April 15, 2005.
Quantity in commerce
100 kits
Distribution
VA, OH, TX, CA, IL, and FL
Product codes and lots
Lot number 1004328