Class 2 Device Recall Protective Restraint

• Date Initiated by Firm: April 12, 2019
• Create Date: October 25, 2019
• Recall Status: Terminated on July 22, 2020
• Recall Number: Z-0194-2020
• Recall Event ID: 82534
• Product Classification: Restraint, protective - Product Code FMQ
• Product: Posey Connected Twice-As-Tough Cuffs
• Code Information: Model # 2796 with Lots #'s : 7109T007, 7112T001, 122T083, 7185T008, 7192T034, 7194T051, 7200T090, 7250T051, 7263T007, 7313T054, 7355T062, 7361T073, 8018T059, 8038T045, 8041T035, 8081T066, 8122T001, 8122T088, 8129T006, 8130T065, 8344T055, 8347T174, 8346T075, 9002T023, 9064T123, and 9064T124. Model # 2797 with Lots #'s : 7038T010, 7044T051, 059T038, 7061T050, 7088T028, 7089T002, 7090T054, 7100T047, 7103T054, 7114T090, 7114T091, 7151T004, 7154T006, 7156T124, 7163T046, 7165T087, 7178T035, 7181T003, 7185T014, 7186T103, 7271T210, 7284T006, 7284T105, 7291T094, 7317T014, 7340T102, 7347T110, 7354T115, 8004T054, 8024T013, 8025T071, 8047T033, 8055T001, 8071T003, 8096T004, 8106T002, 8113T040, 8115T078, 8117T039, 8178T135, 8183T060, 8249T077, 8261T064, 8263T079, 8270T075, 8278T008, 8281T061, 8284T083, 8304T004, 8305T073, 8312T067, 8320T069, 8330T023, 8331T122, 9007T056, 9008T030, 9015T047, 9017T073, 9063T004, 9064T121, and 9064T122.
• Recalling Firm/ Manufacturer: TIDI PRODUCTS; 272 E Deerpath; Lake Forest IL 60045-5314
• For Additional Information Contact: Customer Service; 800-447-6739
• Manufacturer Reason for Recall: Not meeting design specifications.
• FDA Determined Cause: Process control
• Action: On April 5th the firm sent letters to their customers stating the following: Next Steps: 1. Ensure that all caregivers and users of the Posey Connected Twice-As-Tough (TAT) Cuffs (nos. 2796 and 2797) are made aware of this Recall Notice. 2. Refer to the enclosed TAT Cuff Lot Number List (Attachment 1) and check your inventory to determine if your facility has any affected units. 3. Destroy affected TAT Cuff(s) by following the enclosed TAT Cuff Destruction Instructions (Attachment 2). Dispose of damaged products per your facilitys policy for BIOHAZARDOUS material. 4. Complete the enclosed Customer Response and Proof of Destruction Form and return this form to the TIDI Products Regulatory Department. 5. Product Replacement  Product shipment will resume on or around April 12, 2019. Replacement orders will be fulfilled as Customer Response and Proof of Destruction Forms are received. Note: If you have zero inventory of affected product, please enter 0 in the Quantity section and return form as required. Distribution of this Recall Notice: Please distribute this Recall Notice to appropriate individuals within your organization and to any organization where the potentially affected devices were transferred or sold. Please maintain awareness of this notice and resulting action for a minimum of two years to ensure effectiveness of this corrective action. In cases where customers opt not to proceed with completion of the recall requirements described above, TIDI Products cannot accept any responsibility for safety related issues or legal liabilities caused by the failure to respond to this Recall Notice. We regret any inconvenience that this Recall Notice may cause. Note: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Additional Comment If you have any further questions or require assistance completing the Cust
• Quantity in Commerce: 7692 (7615 USA and 77 OUS)
• Distribution: AK, AR, CA, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MN, MO, MS, MT, NC, NH, NJ, NM, NY, PA, SC, TN, TX, UT, VA, VT, WI, and WV CANADA, FRANCE, and THE NETHERLANDS
• 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.