Medline Nerve Block Trays Recalled Over Sterilization Calibration Issues
Medline is recalling 448 units of its BASIC NERVE BLOCK TRAY W/LINEN (Model PAIN0150C) due to calibration issues with sterilization and packaging equipment that could affect 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 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: This is an FDA Class II recall involving a medical device where sterilization calibration issues could compromise the sterility assurance level, posing a potential risk of infection or other adverse health consequences.
Plain-English summary
Medline Industries, LP is recalling 448 units of the Medline Convenience Kit containing the BASIC NERVE BLOCK TRAY W/LINEN, Model Number PAIN0150C. The product code is PAIN0150C with UDI-DI 10193489819571, and the lot number is 21JBV886.
The recall is being issued because Medline identified issues related to the calibration of equipment used to sterilize and package the devices. While all products were exposed to the validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
The devices were distributed worldwide, including US nationwide. No illnesses or injuries have been reported in connection with this recall.
Consumers or healthcare facilities in possession of the recalled product should contact Medline for return instructions and a replacement. The recall was classified by the FDA as a Class II recall, indicating a potential risk of temporary adverse health consequences if the sterility of the device is compromised.
The recalled product
- Product
- Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Tray
- 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)
- 21JBV886(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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