TIDI PRODUCTS: Posey Connected Twice-As-Tough Cuffs

Recall number

Z-0194-2020

Recalling firm

TIDI PRODUCTS

Product

Posey Connected Twice-As-Tough Cuffs

Status

Terminated

Initiated

2019-04-12

Posted

not on file

Terminated

2020-07-22

Reason

Not meeting design specifications.

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

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

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

FMQ

Firm FEI

3014634341

Firm city

Lake Forest

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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