GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17
FDA device recall Z-2027-2024 · posted 2024-06-06 · Open, Classified
Recall details
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Reason for recall
- Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
- Action taken
- Recall letters dated and issued on 4/9/2024 by the recalling firm explained the safety issue and actions to be taken by the customer/user. Those actions were to not use the affected products listed in the Affected Product Details section of the letter, use an alternate cuff for NIBP monitoring, and destroy all affected product per the customer facility procedures. A photograph of the product was embedded in the letter to show where to find the product name, model number, and GTIN number. The letter informs the consignee that GE HealthCare will replace the affected products with CRITIKON SOFT-CUF Blood Pressure Cuffs and a GE HealthCare representative will contact the consignee to arrange for this correction. An Acknowledgement Form was enclosed for completion and return.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DXQ
- Quantity affected
- 23,180/20-cuff boxes
- Distribution
- US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MO, MS, NC, NJ, NM, OH, PA, TN, and TX.
- Date initiated
- 2024-04-09
- Date posted
- 2024-06-06
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONE-CUF (K230145) | Ge Medical Systems Information Technologies, Inc. | 2023-03-14 |