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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = GCJ
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