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Recall Observatory FDA recall evidence

Device product

Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C

Z-2116-2026

January 07, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98642
Status
Ongoing
Classification
Class II
Quantity
448 units
Official record key
device-enforcement:Z-2116-2026

Official wording

Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Code information: 1) PAIN0150C, UDI-DI: 10193489819571(each), 40193489819572(case), Lot Number: 21JBV886

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.