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Open, Classified

ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A

FDA Recall Z-3072-2024 · Posted 2024-09-06

Recall StatusOpen, Classified
Product CodeOJH
Date Initiated2024-06-18
Product Quantity315 units

Reason for Recall

A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.

Firm Action

Medline Industries issued a Recall notice to its consignees on 06/18/2024 via email. The notice explained the issue, potential risk, and directed the product to be stickered to instruct the used to remove the recalled component from the kit and replace from sterile supply. Distributors or those who have transferred the product were directed to notify those to whom the product was distributed of the recall. For questions, contact the Recall Department at 866-359-1704 or [email protected].

Root Cause

Process change control

Distribution Pattern

US: TX, IL, CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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