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U.S. Department of Health and Human Services

Class 2 Device Recall SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve

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  Class 2 Device Recall SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve see related information
Date Initiated by Firm February 08, 2021
Create Date April 06, 2021
Recall Status1 Terminated 3 on February 17, 2023
Recall Number Z-1366-2021
Recall Event ID 87432
510(K)Number K150549  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Code Information Catalogue Number: 100-36-01 Lot Number: 0818-009
Recalling Firm/
Manufacturer		 Sharp Medical Products
14362 N Frank Lloyd Wright Blvd
Scottsdale AZ 85260-8846
For Additional Information Contact Carolyn Urish
630-232-8002 Ext. 5
Manufacturer Reason
for Recall		 Non-conformity (holes/punctures or deep creases) in the sterile barrier.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 02/08/2021 the firm began notifying customers and received confirmation that affected lot was still on customers shelves. On 03/03/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via certified US mail informing customers that they have become aware of product that either have holes or deep creases in the sterile barrier that makes the product unsafe for use and could lead to patient infection, sepsis, or death if used. Customer are instructed: 1.That any/all remaining units on their shelves should be disposed of in the trash. 2. Complete "MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and scan and send via email to Carolyn.urish@sharpmedicalproducts.com or send via mail to attention of Carolyn Urish at 14362 N Frank Lloyd Wright, Scottdales AZ, 85260. Any questions or further guidance - contact the Recalling Firm at email carolyn.urish@sharpmedicalproducts.com or by phone at 630-232-8002 ext. 5 Monday through Friday 8:00 a.m. to 4:30 p.m. Mountain Time.
Quantity in Commerce 129 units (63 units for Human-use and 66 units for Non-Human use)
Distribution U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None
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 = GCJ and Original Applicant = Sharp Medical Prducts, LLC
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