Recall Z-1078-2021 ยท LYU Accessory, Surgical Apparel
Cardinal Health 200, LLC
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
| Date | Jan 7, 2021 |
| Status | Terminated |
| Reason | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. |
| Root cause | Process change control |
| Action | URGENT MEDICAL DEVICE CORRECTION NOTICE notification letters dated 1/7/21 were sent to customers. Actions requested on your part: 1) REVIEW your inventory for affected product. 2) QUARANTINE affected product per Attachment 1 within your inventory 3) AFFIX one WARNING LABEL included with this notification to the front of each ChemoPlus" and ChemoBloc" Chemo Spill and Preparation/Administration kits so that it is clearly visible to clinicians, instructing them to remove the affected gown component prior to use. 4) COMMUNICATE this action with all personnel the need to remove the gowns prior to |
| Quantity | 137,346 kits |
| Distribution | Global Distribution. US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002064 | COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL Wrp Asia Pacific Sdn. Bhd., Nov 28, 2000 |