Recall Z-1889-2010 ยท FMI Needle, Hypodermic, Single Lumen
Multi-Med, Inc.
22ga x 1" Right Angle Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports.
| Date | Jul 2, 2010 (initiated May 26, 2010) |
| Status | Terminated |
| Reason | FDA sample determined the needles to be coring. |
| 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 |
| Quantity | 5,000 |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K891919 | INTRAVASCULAR ADMINISTRATION SET Multi-Med, Inc., May 5, 1989 |