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U.S. Department of Health and Human Services

Class 2 Device Recall Chiba Needle Marked

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  Class 2 Device Recall Chiba Needle Marked see related information
Date Initiated by Firm June 19, 2009
Date Posted September 20, 2009
Recall Status1 Terminated 3 on October 23, 2009
Recall Number Z-1935-2009
Recall Event ID 52781
Product Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005.

General purpose aspiration Cytology Biopsy Needle
Code Information Lot number 091386.
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		 Two unsealed pouches were identified after product release, compromising product sterility.
FDA Determined
Cause 2		 Process control
Action Initial notification to consignees was issued via telephone on June 19, 2009 and by certified mail on June 30, 2009. They were instructed to examine their inventory and quarantine product subject to the recall. If the product was further distributed, they were advised to identify their customers and notify them at once of the recall via the recall letter. A Return Authorization number was provided. Forty of 50 units in distribution were returned from the two customers.
Quantity in Commerce 50 units
Distribution US - CA and WI.
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.
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