Recall Z-0964-2024— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-12-21. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A. Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-21
- Firm location
- Northfield, IL, United States
Product description
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Reason for recall
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
Data sourced from openFDA. This site is unofficial and independent of the FDA.