Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0852-05

Arrow Continuous Nerve Block Needle, Latex-Free* Rx only*Sterile*Arrow International Inc., 2400 Bernville...

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2005-02-17 / Terminated / root cause: manufacturing process

Arrow International Inc began a recall of Arrow Continuous Nerve Block Needle, Latex-Free* Rx only*Sterile*Arrow International Inc., 2400 Bernville, Road, Reading, PA 19605 USA on . The reason FDA records is "Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0852-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arrow International LLC (subsidiary of Teleflex Incorporated)
Product
Arrow Continuous Nerve Block Needle, Latex-Free* Rx only*Sterile*Arrow International Inc., 2400 Bernville, Road, Reading, PA 19605 USA
Product code
CAZ Anesthesia Conduction Kit
Reason for recall
Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process.
Root cause tag
manufacturing process
FDA root cause
Other
Action
Consignees were notifed by letter on/about 02/17/2005
Distribution
Nationwide, Africa , France, Holland, Rotterdam
Product codes and lots
Product #AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18040-N, AB-18080-N, AB-18110-N, AB-18140-N, AB-19604-K, AB-19604-S, AB-19608-K, AB-19608-S, AB-20604-K, AB-20604-S, AB-20608-K, AB-20608-S