Z-0194-2020Class II

Posey Connected Twice-As-Tough Cuffs

Name: Z-0194-2020 Posey Connected Twice-As-Tough Cuffs
Creator: Tidi Products
Published: 2019-04-12
License: https://open.fda.gov/license/

Tidi Products, LLC / initiated 2019-04-12 / Terminated / root cause: manufacturing process

FDA source

TIDI PRODUCTS began a recall of Posey Connected Twice-As-Tough Cuffs on 2019-04-12. FDA classified it as Class II and gives the reason as "Not meeting design specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0194-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-12
Posted: 2019-10-25
Terminated: 2020-07-22
Recalling firm: Tidi Products, LLC
Product: Posey Connected Twice-As-Tough Cuffs
Product code: FMQ Restraint, Protective
Reason for recall: Not meeting design specifications.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0194-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0194-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-25

Product code FMQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)