Recall Z-0569-2022 ยท INN Chair, Adjustable, Mechanical
R82 A/S
R82 by ETAC Push Brace for High-Low
| Date | Dec 8, 2021 |
| Status | Terminated |
| Reason | The chrome surface of the push brace can crack during use, potentially cutting the user. |
| Root cause | Process control |
| Action | A notification dated 12/10/2021 was sent to customers by R82 A/S notifying them of a Field Safety Notice concerning Push Brace 8910545 attached to patient mobility chairs. The notice communicates the chrome surface's potential for cracking during use, posing a risk of cutting the caregiver utilizing the push brace. The firm instructs customers to visually inspect recalled push braces before use and should be disposed of if any are detected. The firm also communicated that customers with affected push braces will receive replacements. If product has been further distributed, the notice needs to |
| Quantity | 396 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of North Carolina and California and the countries of Czech Republic, Finland, Germany, Greece, Holland, Italy, Japan, Norway, Poland, Russia, Sweden, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.