FDA Device recall Z-1546-2020
Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153 by Medline Industries, citing voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1546-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-10 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medline Industries |
| Distribution | US |
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.
Identifiers
| code_info | REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1546-2020%22
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