FDA Device

22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports.

Hazard

FDA sample determined the needles to be coring.

What You Should Do

Remedy

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 astarkey@multimedinc.com.

Products

22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports.
Brand
Multi-Med, Inc.
UPC
Model number 10600218 Lot No 9B020M

Units Affected

5169