Food, drugs, devices › Medline Industries Inc

Device recall: Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test car

FDA enforcement event 87561 · Class II · initiated 15 Mar 2021 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordNorthfield, IL

Medline Industries Inc (Northfield, IL) initiated this device recall on 15 Mar 2021; FDA lists 1 product record under event 87561, classified Class II.

FDA defines Class II as 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. 89% of the 900 device enforcement events initiated in 2021 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Medline Industries Inc has 61 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Medline Industries Inc, Northfield, IL.

Reason for recall

"Possible false negative or false positive results due to the product being compromised during shipment."

Distribution

"US Nationwide distribution in the state of Ohio."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1407-2021	Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.	24 each	Class II	Ongoing	21 Apr 2021

Context

89%of 2021 device events are Class II900 events that year

1product record in this eventfirm median: 1

61events on this register for the firm

Other enforcement events for Medline Industries Inc

Initiated	Product (first record)	Type	Class	Records
21 Jul 2022	Medline CHEST TUBE REORDER NO: DYNJ36762A	Device	Class II	1
8 Nov 2021	Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC	Drug	Class II	1
27 Oct 2021	EVLP Convenience Pack/Kit	Device	Class II	5
6 Aug 2021	NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Of	Device	Class II	2
1 Jul 2021	Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irr	Device	Class II	4
25 May 2021	Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft a	Device	Class II	1
14 May 2021	READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use O	Drug	Class III	1
30 Apr 2021	Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recov	Device	Class II	1
25 Jan 2021	RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglob	Device	Class II	1
15 Jan 2021	S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the	Device	Class III	1

All 61 events for Medline Industries Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Possible false negative or false positive results due to the product being compromised during shipment."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution in the state of Ohio."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.