Medline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
Medline Industries is recalling 36,199 surgical convenience kits nationwide because cannula components do not meet ISO 80369-7 dimensional requirements, posing a risk of leaking or breaking during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves surgical kits with cannula components that may leak or break during use, a hazard that could cause adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 36,199 surgical convenience kits distributed nationwide. The affected products include various open heart, CABG, vein harvest, and transplant packs, such as the Open Heart Pack A & B and the CABG Accessory Pack. The recall is due to cannula components within these kits that do not conform to ISO 80369-7 dimensional requirements.
The non-conforming cannula components may contribute to leaking or breaking during use. The source text does not report any illnesses, injuries, or deaths associated with this recall. The FDA has classified this as a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers should check their inventory for the specific Medline product numbers and lot numbers listed in the official recall notice. If you have these kits, stop using them and contact Medline Industries for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 36,199
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)
- Medline product number/SKU DYNJ04584L
- UDI/DI 10198459212291 (each) 40198459212292 (case)
- Lot number 26DMA968
- Medline product number/SKU DYNJT5715A
- UDI/DI 10198459505126 (each) 40198459505127 (case)
- Lot number 26CMI506
- Medline product number/SKU DYNJ85751
- UDI/DI 10195327542917 (each) 40195327542918 (case)
- Lot number 26BMB785
- Medline product number/SKU DYNJ53741N
- UDI/DI 10198459560088 (each) 40198459560089 (case)
- Lot number 26BBG793
- Medline product number/SKU DYNJ80701A
- UDI/DI 10198459026195 (each) 40198459026196 (case)
- Lot number 26BBF945
- Medline product number/SKU DYNJ67308C
- UDI/DI 10198459676666 (each) 40198459676667 (case)
- Lot number 26BBF661
- Medline product number/SKU DYNJ89451B
- UDI/DI 10198459637674 (each) 40198459637675 (case)
Distribution
Distributed nationwide across the United States.
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