Recall Z-1661-2008 ยท JOW Sleeve, Limb, Compressible
Ascent Healthcare Solutions, Inc.
Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures.
| Date | Sep 19, 2008 (initiated Mar 11, 2008) |
| Status | Terminated |
| Reason | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
| Root cause | Process control |
| Action | A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at mbarton@ascenths.com. |
| Quantity | 360 of 365 |
| Distribution | Class II Recall - Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012403 | VANGUARD REPROCESSED COMPRESSION GARMENT Vanguard Medical Concepts, Inc., Oct 17, 2001 |