Recall Z-0055-2021 ยท IKX Aid, Transfer
Medline Industries Inc
Quick Release Gait Belt, 60
| Date | Sep 15, 2020 |
| Status | Open, Classified |
| Reason | The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation. |
| Root cause | Process design |
| Action | On Sep 15 2020 the firm sent an notification to its customers via email, with the following instructions: REQUIRED ACTION: 1. Immediately check your stock for the specific kit number and the affected kit lot number in the attached list. Quarantine any kits with the listed lot numbers. If you dont have any of the lots listed above skip to step 3. 2. Remove affected Gait Belts prior to use of the Fall Prevention Kit. Please be sure NOT to use the recalled Gait Belts and return those to Medline. Medline will supply replacement belts at no charge to you. 3. Please return the completed enclosed ver |
| Quantity | 13,500 units |
| Distribution | Domestic Distribution Only: IL, MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.