FDA · Medical device recall

Automatic Cutting Needle… and 4 more products

March 7, 2011

Date posted by the FDA: March 7, 2011
Status: Terminated
Filed by: Remington Medical Inc.
Reason: There is a potential for the needle hubs to break during use.
Distribution pattern: U.S. Nationwide

5 products in this recall

Automatic Cutting Needle…

Product: Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-14010MLL, 14ga (2.1mm) x 10cm (10), Remington Medical, Inc.
Quantity: 727 units
Codes and lots: Lot number: 083384
Recall started: Feb. 7, 2011
Device type: Instrument, Biopsy
Root cause (FDA): Device Design
What the company told customers: 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.
Recall number: Z-1573-2011

Automatic Cutting Needle…

Product: Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.
Quantity: 23022 units
Codes and lots: Lot numbers: 090162 090289, 905416, 090684, 090758 and 090862.
Recall started: Feb. 7, 2011
Device type: Instrument, Biopsy
Root cause (FDA): Device Design
What the company told customers: 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.
Recall number: Z-1574-2011

Automatic Cutting Needle…

Product: Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.
Quantity: 4867 units
Codes and lots: Lot numbers: 083383 and 090582
Recall started: Feb. 7, 2011
Device type: Instrument, Biopsy
Root cause (FDA): Device Design
What the company told customers: 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.
Recall number: Z-1575-2011

Automatic Cutting Needle…

Product: Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.
Quantity: 10101 units
Codes and lots: Lot numbers: 090212, 091351 and 093136
Recall started: Feb. 7, 2011
Device type: Instrument, Biopsy
Root cause (FDA): Device Design
What the company told customers: 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.
Recall number: Z-1576-2011

Automatic Cutting Needle…

Product: Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.
Quantity: 8161 units
Codes and lots: Lot numbers 092453, 092743, 092956 and 100646
Recall started: Feb. 7, 2011
Device type: Instrument, Biopsy
Root cause (FDA): Device Design
What the company told customers: 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.
Recall number: Z-1577-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1573-2011, Z-1574-2011, Z-1575-2011, Z-1576-2011, Z-1577-2011. The agency record governs; check it and the company before acting.

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