Multi-Med, Inc. Recalls
Showing 1-2 of 2 recalls
22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports.
FDA sample determined the needles to be coring.
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.
All Med Medical 19ga x .50" Winged Administration Set w/Y Site Model # M195Y Reorder # 50-1912
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.