Z-2117-2014Class II

CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case...

Name: Z-2117-2014 CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case...
Creator: Dynarex Corporation
Published: 2014-07-02
License: https://open.fda.gov/license/

Dynarex Corp. / initiated 2014-07-02 / Terminated / root cause: manufacturing process

FDA source

Dynarex Corporation began a recall of CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China... on 2014-07-02. FDA classified it as Class II and gives the reason as ""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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2117-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-02
Posted: 2014-07-25
Terminated: 2017-04-20
Recalling firm: Dynarex Corp.
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.
Product code: CBP Valve, Non-Rebreathing
Reason for recall: "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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Voluntary Device Recall letters (dated 7/01/14) and recall verification forms were sent to customers via US Postal First Class Mail on 7/02/14. The letters instructed customers to check their inventory for the specific lots, discontinue distributing them, and quarantine them immediately. Customers were to promptly contact Dynarex Credit & Return Representative Avi Celnick at 1-845-365-8200 ext. 6644 to arrange for product return and obtain an RGA #. For questions, please call Dynarex's toll free number 1-888-396-2739.
Quantity in commerce: Domestic: 208 cases; Foreign: 42 cases
Distribution: Worldwide Distribution -- USA, Canada, and Mexico.
Product codes and lots: Lot Numbers 28619 & 28621

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2117-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2117-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-25

Product code CBP

K052743Class IIDynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921Dynarex Corp. / cleared 2005-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)