Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
Recall
- Recall Number
- Z-1078-2021
- Event Number
- 87145
- Firm
- Cardinal Health 200, LLC
- FEI Number
- 3001236905
- Product Code
- LYU
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- January 7, 2021
- Terminated
- February 14, 2024
- Address
- 3651 Birchwood Dr, Waukegan, IL, 60085-8337
Description
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
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 use. 5) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product action. 6) RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to [email protected], whether or not you have affected product. Please contact the Customer Service group for any questions or to arrange for credit and return of any product: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other customers888-444-5440 For questions related to the notification, additional warning labels requests and/or acknowledgement form, please contact the market action team at: [email protected] or call 800-292-9332.
Global Distribution. US Nationwide.
137,346 kits