Medline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk
Medline is recalling 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.
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: This is an FDA Class II medical device recall involving dialysis equipment with potential for non-sterile product use if the package seal is compromised. The risk-of-harm nature of dialysis procedures warrants a High severity rating, despite no reported illnesses or injuries.
Plain-English summary
Medline Industries is recalling 90 units of its DIALYSIS PACK (REF DYNJ36932A), a medical procedure convenience kit. The recall was issued because certain kits packaged in breather pouch lot 323080002 may result in non-sterile product if the vendor seal is opened or compromised.
The vendor seal is designed to maintain the sterility of the product, which is essential in medical procedures. This recall addresses the potential for loss of sterility if the seal is breached.
Consumers and healthcare providers with affected units should stop using them and contact Medline Industries. The affected lot is 23LBL499 (UDI/DI 40195327429752 for individual units and 10195327429751 for cases). Affected units were distributed in the United States, Canada, and Panama.
The recalled product
- Product
- Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 90
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)
- UDI/DI 40195327429752 (each)
- 10195327429751 (case)
- Lot Numbers: 23LBL499
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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