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.
This recall has been terminated (originally issued July 25, 2014).
- Company
- Dynarex Corporation
- Recall Initiated
- July 2, 2014
- Posted
- July 25, 2014
- Terminated
- April 20, 2017
- Recall Number
- Z-2117-2014
- Quantity
- Domestic: 208 cases; Foreign: 42 cases
- Firm Location
- Orangeburg, NY
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- USA, Canada, and Mexico.
Lot / Code Info
Lot Numbers 28619 & 28621
Root Cause
Employee error
Action Taken
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.