Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1889-2010

22ga x 1" Right Angle Huber Needle This product is a small gauge needle intended for single use hypodermic...

Multi-Med, Inc. / initiated 2010-05-26 / Terminated

Multi-Med, Inc. began a recall of 22ga x 1" Right Angle Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports on . The reason FDA records is "FDA sample determined the needles to be coring". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1889-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Multi-Med, Inc.
Product
22ga x 1" Right Angle Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports.
Product code
FMI Needle, Hypodermic, Single Lumen
Reason for recall
FDA sample determined the needles to be coring.
FDA root cause
Pending
Action
The firm, Multi Med, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 26, 2010 to their sole consignee Navilyst Medical, Inc., via email and overnight courier with signature notification. The letter describes the product, problem and action to be taken by customer. The customers was instructed to immediately examine their inventory and quarantine product subject to recall, if the product was distributed to others customers, identify and notify them at once and include recall notification letter,. Recall has been initiated due to FDAs sample analysis that these needles may core implanted port septums. If you have any questions, call me, Sue Starkey, at 603-357-8733 or via email at [email protected].
Quantity in commerce
5,000
Distribution
Worldwide distribution
Product codes and lots
Model number 10600219 Lot No 9B017M