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U.S. Department of Health and Human Services

Class 2 Device Recall EasyPoint Needle

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  Class 2 Device Recall EasyPoint Needle see related information
Date Initiated by Firm February 05, 2024
Date Posted March 14, 2024
Recall Status1 Open3, Classified
Recall Number Z-1293-2024
Recall Event ID 93981
510(K)Number K133635  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product EasyPoint Needle, 25G x 5/8", REF: 82091
Code Information UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027
Recalling Firm/
Manufacturer		 Retractable Technologies, Inc.
511 Lobo Ln
Little Elm TX 75068-5295
For Additional Information Contact
972-294-1010
Manufacturer Reason
for Recall		 The needle cannula of a retractable needle may detach from the needle holder in the patient.
FDA Determined
Cause 2		 Process control
Action On 2/5/24, recall notices were sent to customers and distributors who were asked to do the following: 1) Segregate, quarantine, and discontinue use and distribution of affected devices. 2) Inform all personnel who have received or are receiving affected devices that they should not use affected devices. 3) If affected product was further distributed, notify these additional customers immediately. When notifying customers include a copy of the recall notice, label images, and the response form. 4) Complete and return the response form to rtiservice@retractable.com Customers with additional questions can email the firm at regulatory@retractable.com
Quantity in Commerce 477,600
Distribution US Nationwide distribution including in the states of NY, FL, IL, MA, UT, NJ, AZ, MO, WA, NC, CA, TX, NV, IN, PA, VA, IA, GA, TN, MI, OH, OK, CO, OR, SC, MN, CT.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = RETRACTABLE TECHNOLOGIES, INC.
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