Z-2358-2019Class II

Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline

Name: Z-2358-2019 Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
Creator: Medline Industries Inc
Published: 2019-08-09
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2019-08-09 / Open, Classified / root cause: packaging

FDA source

Medline Industries Inc began a recall of Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline on 2019-08-09. FDA classified it as Class II and gives the reason as "Samples in the identified lot were found to have incomplete or open packaging seals". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2358-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-08-09
Posted: 2019-08-23
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline
Product code: EYN Tray, Irrigation, Sterile
Reason for recall: Samples in the identified lot were found to have incomplete or open packaging seals.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Consignees were notified via first class mail on August 9, 2019. The letter requested the following: 1. Immediately check your stock for item number DYNC2303 and the affected lot number, 19CAB954. Quarantine all affected product. Destroy all product belonging to the affected lot numbers listed on the destruction form. 2. Please return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form as indicated. When we receive your completed destruction form your account will be issued a credit, if applicable. 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.
Quantity in commerce: 11962 trays
Distribution: US nationwide distribution
Product codes and lots: Lot Number 19CAB954

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2358-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2358-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-09-04	2019-08-23

Product code EYN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)