Medline Basic Nerve Block Tray sterilization calibration issue
Medline is recalling Basic Nerve Block Trays due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the devices.
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 recall involving a risk-of-harm product (medical device with potential sterility compromise). No reported illnesses or injuries are stated in the source text, but the potential impact on sterility assurance level of medical devices represents a significant risk of harm that justifies a High severity classification.
Plain-English summary
Medline Industries, LP is recalling the Medline Convenience Kit: Basic Nerve Block Tray with Linen (Model Number PAIN0150C) due to calibration issues with the equipment used to sterilize and package the devices. Although all products were exposed to validated sterilization and packaging cycles, identified calibration problems have the potential to impact the sterility assurance level (SAL) of the recalled products.
The recalled product has been distributed worldwide with US nationwide distribution. The recalled lot is identified as Lot Number 21JBV886, with UDI-DI 10193489819571 (each) and 40193489819572 (case). A total of 448 units are affected by this recall.
Patients and healthcare providers who have received or are using these devices should contact Medline for further guidance. The recall is being conducted as a Class II device recall due to potential sterility issues.
The recalled product
- Product
- Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
- Manufacturer
- Medline Industries, LP
- Affected units
- 448
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 (4)
- 1) PAIN0150C
- UDI-DI: 10193489819571(each)
- 40193489819572(case)
- Lot Number: 21JBV886
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP 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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