Z-0194-2020 Class II Terminated
FDA device recall Z-0194-2020 was initiated by TIDI PRODUCTS on April 12, 2019 and is designated Class II. Reason for recall: Not meeting design specifications. The recall status is terminated (terminated July 22, 2020). Affected quantity: 7692 (7615 USA and 77 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- April 12, 2019
- Termination Date
- July 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7692 (7615 USA and 77 OUS)
Product Description
Posey Connected Twice-As-Tough Cuffs
Reason for Recall
Not meeting design specifications.
Distribution Pattern
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
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.