Recall Z-2027-2024 ยท DXQ Blood Pressure Cuff
GE Medical Systems Information Technologies Inc
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B-L, ONE-CUF, ADULT LONG, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 5. ONEA2-2A, ONE-CUF, ADULT, DINACLICK 80369-5
| Date | Jun 6, 2024 (initiated Apr 9, 2024) |
| Status | Open, Classified |
| Reason | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. |
| Root cause | Under Investigation by firm |
| Action | 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 SOF |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230145 | ONE-CUF Ge Medical Systems Information Technologies, Inc., Mar 14, 2023 |