Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-14010MLL, 14ga (2.1mm) x 10cm (10), Remington Medical, Inc.

FDA device recall Z-1573-2011 · posted 2011-03-07 · Terminated

Recall details

Recalling firm

Remington Medical Inc.

Reason for recall

There is a potential for the needle hubs to break during use.

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.

Root cause

Device Design

Status

Terminated

Product code

KNW

Quantity affected

727 units

Distribution

U.S. Nationwide

Date initiated

2011-02-07

Date posted

2011-03-07

Date terminated

2011-08-12

Location

Alpharetta, GA

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