Recall Z-0194-2020 ยท FMQ Restraint, Protective
TIDI PRODUCTS
Posey Connected Twice-As-Tough Cuffs
| Date | Apr 12, 2019 |
| Status | Terminated |
| 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 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.