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U.S. Department of Health and Human Services

Class 2 Device Recall Acuject Variable Injection Needle

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  Class 2 Device Recall Acuject Variable Injection Needle see related information
Date Initiated by Firm June 14, 2019
Create Date July 27, 2019
Recall Status1 Terminated 3 on April 02, 2021
Recall Number Z-2089-2019
Recall Event ID 83135
510(K)Number K941305  
Product Classification endoscopic injection needle, gastroenterology-urology - Product Code FBK
Product Acuject Variable Injection Needle
Code Information Lot Code W413079; Catalog Number VIN-25; Expiration Date 10/24/2021; UDI Number (01)00827002225268(17)211024(10)W4136079
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc.
4900 Bethania Station Rd
Winston Salem NC 27105-1203
For Additional Information Contact
336-744-0157
Manufacturer Reason
for Recall		 Potential for occluded injection needles.
FDA Determined
Cause 2		 Employee error
Action Wilson-Cook Medical notified their customer on about 06/14/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. The letter instructed customers to examine inventory for affected devices, quarantine any affected devices, notify customers if the product has been further distributed, and return affected devices to Cook China as soon as possible. The customer was also instructed to complete the provided Recall Return Response form and send it to Cook China.
Quantity in Commerce 24
Distribution Distributed to China
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 = FBK and Original Applicant = WILSON-COOK MEDICAL, INC.
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