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U.S. Department of Health and Human Services

Class 2 Device Recall Remington Medical, Inc. Automatic Cutting Needle

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  Class 2 Device Recall Remington Medical, Inc. Automatic Cutting Needle see related information
Date Initiated by Firm February 07, 2011
Date Posted March 07, 2011
Recall Status1 Terminated 3 on August 12, 2011
Recall Number Z-1574-2011
Recall Event ID 57885
510(K)Number K040266  
Product Classification Soft Tissue Biopsy Needle - Product Code KNW
Product Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.
Code Information Lot numbers: 090162 090289, 905416, 090684, 090758 and 090862.
Recalling Firm/
Manufacturer		 Remington Medical Inc.
6830 Meadowridge Ct.
Alpharetta GA 30005
For Additional Information Contact Lynne Buchanan-Kopp
770-888-8520
Manufacturer Reason
for Recall		 There is a potential for the needle hubs to break during use.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 23022 units
Distribution U.S. Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = REMINGTON MEDICAL, INC.
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