FDA Medical devices recall ·
MEDLINE OPEN HEART PACK recall
- Recall number
- Z-0121-2025
- Date
- (initiated August 28, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 123 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDLINE OPEN HEART PACK, REF DYNJ66216C
Why was it recalled?
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 40193489853361 (case), 10193489853360 (each), Lot Numbers: 23LBM368, 23LBH354
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0121-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.