Recall Z-2117-2014 ยท CBP Valve, Non-Rebreathing
Dynarex Corporation
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.
| Date | Jul 25, 2014 (initiated Jul 2, 2014) |
| Status | Terminated |
| 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. |
| 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 | Domestic: 208 cases; Foreign: 42 cases |
| Distribution | Worldwide Distribution -- USA, Canada, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 Dynarex Corp., Dec 22, 2005 |