Device product

Control, Calibrator Verified, Triage BNP, Model ALR88755

Z-3054-2020

July 28, 2020

Class II

Product summary

Firm: Medline Industries Inc
Event: Event 86258
Status: Terminated
Classification: Class II
Quantity: 118 units
Official record key: device-enforcement:Z-3054-2020

Official wording

Reason: Product was shipped with refrigeration (ice) instead of frozen (dry ice).

Code information: Lot Number and/or Serial Number: 30718, 407522, 420694, 422646, 430000, 422647N, 422648N, 428255N,428256N, 441421N, 441422N, 441423N

Distribution pattern: Distribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, TX

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product was shipped with refrigeration (ice) instead of frozen (dry ice).