Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.
This recall has been terminated (originally issued March 7, 2011).
- Company
- Remington Medical Inc.
- Recall Initiated
- February 7, 2011
- Posted
- March 7, 2011
- Terminated
- August 12, 2011
- Recall Number
- Z-1576-2011
- Quantity
- 10101 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for the needle hubs to break during use.
Distribution
U.S. Nationwide
Lot / Code Info
Lot numbers: 090212, 091351 and 093136
Root Cause
Device Design
Action Taken
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 recall will follow RMIs Returns Goods Authorization procedure (SOP7-200). All product returns and customer responses will be documented. Upon completion of the recall, the status will be updated and submitted for the FDA's recall closure process.