Medline Medical Procedure Kits With Aortic Cannula Recalled
Medline is recalling 1310 medical procedure kits containing Medtronic Aortic Root Cannula distributed across nine U.S. states. The FDA classified this as a Class I recall.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for medical device recall. Per rubric, FDA Class I recalls are scored at minimum 4 (Severe); no reported deaths or injuries are documented in the source.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits that contain Medtronic Aortic Root Cannula. The affected product kits are labeled as CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, and Z OPEN HEART. The FDA has classified this as a Class I recall.
The recall affects 1310 units distributed to healthcare facilities in California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, and West Virginia.
Specific lot numbers and UDI codes have been issued for identification of affected products. Healthcare facilities and distributors who have received these kits should verify the lot numbers and UDI codes against their inventory. For further information and specific instructions, contact Medline Industries.
The recalled product
- Product
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- device-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- CABG OPNHRT S HSP
- UDI/DI 10195327449650 (EA) 40195327449651 (case)
- Lot Numbers 23IBH906
- 24EBC446
- 24FMC989
- 24GME639
- UDI/DI 10198459089503 (EA) 40198459089504 (case)
- Lot Numbers 24KMB217
- 25AMG162
- CARDIAC CABG
- UDI/DI 10195327490362 (EA) 40195327490363 (case)
- Lot Numbers 23LBV500
- 24DBS178
- 24EBK724
- 24FBL825
- CARDIAC PACK
- UDI/DI 10195327490355 (EA) 40195327490356 (case)
- Lot Numbers 24CBN830
- 24DBS177
- DR D AC PACK
Distribution
Distributed in 9 states:
- CA
- FL
- MN
- NY
- OH
- OR
- PA
- TX
- WV
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