TemporaryFDAOngoing
Can cause harm that is usually temporary.
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
Check the device or its packaging for
UDI/DI 10193489461725 (each) 40193489461726 (case), Lot Numbers: 25LMF813, 25IMF341, 25HBR484, 25FBP179, 25EBJ732, 25DBK745, 25CBK191, 25BBE801, 24LBB945, 24IBT658, 24IBD265, 24GBG100, 24EBC752, 24CBQ893, 24BBJ088, 24ABE008, 23JBA374, 23HBV035, 23GBL681, 23EBK074, 23DBL164, 23DBB447, 23ABV418, 22LBG352, 22IBK243, 22HBX829, 22EBA032, 22DBO915, 22BBR573, 21LBB905, 21IBX719, 21HBG260, 21GBH209, 21DBR261, 21BBJ878.
- Why
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
- Distributed
- US Nationwide distribution.
- Company
- Medline Industries, LP
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0168-2027 · retrieved 15 October 2026
Read the official notice