Recall Z-1577-2011 ยท KNW Instrument, Biopsy
Remington Medical Inc.
Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.
| Date | Mar 7, 2011 (initiated Feb 7, 2011) |
| Status | Terminated |
| Reason | There is a potential for the needle hubs to break during use. |
| Root cause | Device Design |
| Action | Remington Medical consignees were notified via facsimile, email and certified mail starting 02/07/2011. Distributors are requested to communicate this recall to their customers. If a customer does not respond to the recall notice within one week of the recall notification, the customer will be contacted by telephone. If this is unsuccessful, the customer will be sent a second Recall Notice letter and Customer Inventory Reconcile Fax by certified mail by 28 February 2011. If there is no response at that point, RMI will consider the customer's inventory depleted. All return product for this reca |
| Quantity | 8161 units |
| Distribution | U.S. Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040266 | CORE NEEDLE BIOPSY Remington Medical, Inc., Jul 9, 2004 |