Recall Z-1546-2020— Medline Industries Inc

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2020-02-10, terminated 2023-02-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.. Reason: Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging..

Recalling firm
Medline Industries Inc
Classification
Class II
Status
Terminated
Initiated
2020-02-10
Terminated
2023-02-13
Firm location
Northfield, IL, United States

Product description

Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.

Reason for recall

Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

Data sourced from openFDA. This site is unofficial and independent of the FDA.