Recalls / —

—#175718

Product

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

FDA product code

EYN — Tray, Irrigation, Sterile

Device class

Class 2

Medical specialty

Gastroenterology, Urology

Affected lot / code info

Lot Number 19CAB954

Why it was recalled

Samples in the identified lot were found to have incomplete or open packaging seals.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Medline Industries Inc

Address

Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern

US nationwide distribution

Timeline

Recall initiated

2019-08-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #175718. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.