Medline Industries Inc: Medical Device Recall in 2021 - (Recall #: Z-1135-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.

Product Classification:

Class III

Date Initiated: January 15, 2021

Date Posted: March 3, 2021

Recall Number: Z-1135-2021

Event ID: 87184

Reason for Recall:

Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.

Status: Terminated

Product Quantity: 46 units

Code Information:

Model Number: S-O303000; Batch Numbers: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831; Lot Number and/or Serial Number: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831.

Distribution Pattern:

US Nationwide distribution in the states of MS, OH, IL.

Voluntary or Mandated:

Voluntary: Firm initiated