—#185427

Product

Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K

FDA product code: LYU — Accessory, Surgical Apparel
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K002064
Affected lot / code info: Lots: 915025X 915026X 915027X 915028X

Why it was recalled

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 (FDA determination)

Process change control

Action the firm took

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 gmb-fieldcorrectiveaction@cardinalhealth.com, 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: Global Distribution. US Nationwide.

Timeline

Recall initiated: 2021-01-07
Terminated: 2024-02-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185427. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.