Medline CV Anesthesia Room Setup Kits Recalled for Sterility Risk
Medline is recalling 15 CV Anesthesia Room Setup kits because a packaging defect may allow non-sterile product use if the pouch seal is opened.
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: The recall involves a risk-of-harm product (sterility breach) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Medline Industries, LP is recalling 15 units of the CV Anesthesia - Room Setup convenience kit (REF DYNJ905503F). The recall involves kits packaged in breather pouches with lot number 323080002. These products were distributed nationwide in the United States, as well as in Canada and Panama.
The recall was initiated because the packaging may result in the potential use of non-sterile product if the vendor seal of the pouch is opened or unsealed. This defect poses a risk of introducing non-sterile items into a medical procedure setting.
Healthcare facilities and consumers who possess these specific kits should stop using them immediately. The affected products are identified by the specific lot number and reference code listed in the recall notice.
The recalled product
- Product
- Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 15
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 40193489967273 (each)
- 10193489967272 (case)
- Lot Numbers: 23KBQ236
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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