Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
Medtronic is recalling Custom Pack HY10D90R2 sterile perfusion system tubing packs manufactured with insufficient or incomplete welds, which could compromise device integrity 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with a manufacturing defect (incomplete welds) that could affect device integrity. No hospitalizations or injuries have been reported, but the product poses a risk of harm if the defect occurs during use, meeting the High category criterion for risk-of-harm products without reported injuries.
Plain-English summary
Medtronic Perfusion Systems is recalling specific lots of Custom Pack HY10D90R2 3/8 ACC sterile perfusion system tubing packs. These packs may have been manufactured with insufficient or incomplete welds that could compromise the structural integrity of the tubing.
The affected product (Lot number 221451509, with a Use By date of 2022-10-28) was distributed nationwide in the states of Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas (8 tubing packs total).
Healthcare facilities and organizations using this product should discontinue use immediately and contact Medtronic Perfusion Systems for instructions regarding return, replacement, or proper disposal of the affected tubing packs.
The recalled product
- Product
- Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- Affected units
- 8
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 (3)
- GTIN 00763000082987
- Lot number 221451509
- Use By 2022-10-28.
Distribution
Part of a larger recall action
This product is one of 25 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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