Z-2948-2018Class II

Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and...

Name: Z-2948-2018 Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and...
Creator: Medline Industries Inc
Published: 2018-02-01
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2018-02-01 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only on 2018-02-01. FDA classified it as Class II and gives the reason as "Packaged with an incorrect overwrap". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2948-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-01
Posted: 2018-08-29
Terminated: 2020-10-05
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Packaged with an incorrect overwrap.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Medline Industries, Inc., sent an "URGENT RECALL IMMEDIATE ACTION REQUIRED" letter dated February 1, 2018 to their consignees with the required actions to be followed; 1. Immediately check your stock for item number EMZ10051240 and the affected lot number, 3131591, and quarantine all affected product. 2. Please return the completed enclosed destruction form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your account will receive replacement(s). 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc. Should you have any questions, contact the Recall Coordinator at 1-866-359-1704.
Quantity in commerce: 90,870 units
Distribution: US Nationwide Distribution to states of: CA, CT, DE, FL, GA, IN, LA, MA, MD, MN, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA and WV
Product codes and lots: Lot # 3131591

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2948-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2948-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-29

Product code NGT

K142620Class II0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL SyringeExcelsior Medical Corporation / cleared 2014-12-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)