FDA Device recall Z-1909-2021
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
- FDA Device
- Class II
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA by Exact Medical Manufacturing, citing no 510k for the product to be used in a natural or surgical opening to the body.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1909-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-29 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exact Medical Manufacturing |
| Distribution | FL, GA, MT, NY, OH, PR |
Product
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
Reason
No 510k for the product to be used in a natural or surgical opening to the body
Identifiers
| code_info | Lot Numbers: 1912E126 2002E133 2008E227 2008E226 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1909-2021%22
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