ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
This recall is currently active, issued September 6, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- June 18, 2024
- Posted
- September 6, 2024
- Recall Number
- Z-3072-2024
- Quantity
- 315 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
US: TX, IL, CA
Lot / Code Info
UDI/DI Case 40195327334209, UDI/DI Each 10195327334208; Lot Numbers: 23IBJ309, 23GBA500, 23GBA457, 23CBE394, 23BBL312
Root Cause
Process change control
Action Taken
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 recalls@medline.com.