Class 2 Device Recall TMJ Arthroscopy Drape

• Date Initiated by Firm: April 08, 2022
• Create Date: May 12, 2022
• Recall Status: Terminated on June 05, 2024
• Recall Number: Z-1071-2022
• Recall Event ID: 89956
• Product Classification: Drape, surgical, exempt - Product Code PUI
• Product: TMJ Arthroscopy Drape, 85''x 96''
• Code Information: SKU Number 3601; Lot code/Expiration Date: Lot D181232, exp. 05/01/2022; Lot D181982, exp. 07/01/2022; Lot D202232, exp.08/01/2024; Lot D210742, exp. 03/01/2025; Lot D211372, exp. 05/01/2025; Lot D212562, exp. 09/01/2025; Lot D213122, exp. 11/01/2025; and Lot D213402, exp. 12/01/2025. UDI: 50748426008556
• Recalling Firm/ Manufacturer: Microtek Medical Inc.; 1 Ecolab Pl; Saint Paul MN 55102-2739
• For Additional Information Contact: Roman Blahoski; 651-250-4385
• Manufacturer Reason for Recall: Latex content in product was labeled incorrectly as latex free.
• FDA Determined Cause: Under Investigation by firm
• Action: All consignees were contacted on 04/08/2022 via email. Consignees should read the recall instruction, examine their inventory, and quarantine the lots listed in the letter. The consignees should also complete the enclosed response form and email it to recall@ecolab.com. If the consignee has further distributed the product, they should identify and notify their customers of the recall.
• Quantity in Commerce: 12 cases (120 drapes)
• Distribution: Distributed nationwide to CO, PA, and WI.
• 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.