Medline Open Heart Pack (MEDLINE) – Cannulae Component Risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEDLINE OPEN HEART PACK, REF DYNJ66216C
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
UDI/DI 40193489853361 (case), 10193489853360 (each), Lot Numbers: 23LBM368, 23LBH354
Products Sold
UDI/DI 40193489853361 (case), 10193489853360 (each), Lot Numbers: 23LBM368, 23LBH354
MEDLINE INDUSTRIES, LP Northfield is recalling MEDLINE OPEN HEART PACK, REF DYNJ66216C due to Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the thr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Medline issued an UREGENT MEDICAL DEVICE NOTIFICATION to its consignees on 08/28/2024 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee quarantine the product and response to obtain labeling to be placed on the affected inventory. Distributors are directed to notify those to whom they shipped the affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026