FDA Device recall Z-2117-2014
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporatio…
- FDA Device
- Class II
- terminated
- Published 2014-08-06
On 2014-08-06 the FDA classified a Class II recall of CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporatio… by Dynarex, citing "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2117-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-02 |
| Published | 2014-08-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Dynarex |
| Distribution | n/a |
Product
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.
Reason
"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
Identifiers
| code_info | Lot Numbers 28619 & 28621 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2117-2014%22
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