CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for:
FDA device recall Z-2117-2014 · posted 2014-07-25 · Terminated
Recall details
- Recalling firm
- Dynarex Corporation
- 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.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- CBP
- Quantity affected
- Domestic: 208 cases; Foreign: 42 cases
- Distribution
- Worldwide Distribution -- USA, Canada, and Mexico.
- Date initiated
- 2014-07-02
- Date posted
- 2014-07-25
- Date terminated
- 2017-04-20
- Location
- Orangeburg, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 (K052743) | Dynarex Corp. | 2005-12-22 |