—#198012

Product

Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: GTIN 401934899531530, Lot # 22HMH432

Why it was recalled

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm sent a correction notice to its direct consignees on 12/07/2022 by US mail and email. The notice explained the issue and requested the following: "Please check you stock for affected kits and over-labeling will be sent to place on kits to ensure that all labeling is accurate. No kits are to be returned back to Medline. All components are not affected. Our records indicate that these were used as a component in the list of kit(s) purchased from Medline Industries, LP." "If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, LP." "If you have any questions, please contact the Recall Department at 866-359-1704."

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2022-12-07
Posted by FDA: 2023-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.