Recall Z-0312-2024

MEDLINE INDUSTRIES, LP - Northfield · initiated November 1, 2023

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562

Codes / lots: UDI/DI 40193489402446 (case), 10193489402445 (unit): Lot Numbers: 23DMF156, 23CMH030, 23CMD955

Reason for recall

This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.

FDA-determined cause: Under Investigation by firm

Action taken

Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 11/01/2023 via email. The notice explained the issue and requested that the destruction of the affected kits. Consignees were also instructed to notify all parties if the kits were transferred.

Details

Recall number
Z-0312-2024
Initiated
November 1, 2023
Posted by FDA
November 16, 2023
Product code
OFF – Central Venous Catheter Tray
Quantity
1600 kits
Distribution
US Nationwide distribution in the state of California.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0310-2024 Class IIADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245This recall is being issued due to items within the kit have expired prior to the overall kit expiration… 11/01/2023Open, Classified
Z-0311-2024 Class IIPERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561This recall is being issued due to items within the kit have expired prior to the overall kit expiration… 11/01/2023Open, Classified
Z-0313-2024 Class II24 BLOOD CULTURE KIT, REF DYNDH1632This recall is being issued due to items within the kit have expired prior to the overall kit expiration… 11/01/2023Open, Classified
Z-0314-2024 Class IIBLOOD CULTURE KIT, REF DYNDH1647BThis recall is being issued due to items within the kit have expired prior to the overall kit expiration… 11/01/2023Open, Classified