—#192443

Product

Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.

FDA product code: NGT — Saline, Vascular Access Flush
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K082837
Affected lot / code info: Lot #3139133, Exp. 11/01/2022.

Why it was recalled

Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

The recalling firm issued letters dated 3/4/2022 via regular mail informing the customer there was a sterility failure of the exterior of the syringe and in the event a syringe from the affected lot was placed on a sterile field, the sterile field may become compromised. The required actions were to immediately check their stock for the affected lot number, quarantine it, and then destroy it. The enclosed destruction form was to be completed listing the quantity of affected product destroyed, and once the form was returned, they would receive credit. If the product has been transferred to another individual or location, they were to notify them of the recall.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.

Timeline

Recall initiated: 2022-03-04
Terminated: 2023-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192443. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.