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, 23 - 33 CM, 20/BOX; 6. ONE-A2-2A-L, ONE-CUF, ADULT LONG, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 7. ONE-A3-1B, ONE-CUF, LARGE ADULT, 1 TB BAYONET, 31 - 40 CM, 20/BOX; 8. ONE-A3-2A, ONE-CUF, LARGE ADULT, DINACLICK 80369-5, 31 - 40 CM, 20/BOX; 9. ONE-P1-1B, ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM, 20/BOX; 10. ONE-P1-2A, ONE-CUF, INFANT, DINACLICK 80369-5, 08 - 13 CM, , 20/BOX; 11. ONE-P2-1B, ONE-CUF, CHILD, 1 TB BAYONET, 12 - 19 CM, 20/BOX; and 12. ONE-P2-2A, ONE-CUF, CHILD, DINACLICK 80369-5, 12 - 19 CM, 20/BOX.
This recall is currently active, issued June 6, 2024. It was issued by Ge Medical Systems Information Technologies Inc.
- Recall Initiated
- April 9, 2024
- Posted
- June 6, 2024
- Recall Number
- Z-2027-2024
- Quantity
- 23,180/20-cuff boxes
- Firm Location
- Milwaukee, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
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.
Lot / Code Info
No serial numbers are on the blood pressure cuffs. GTIN NUMBERS: ONE-A1-1B - GTIN 00195278573803; ONE-A1-2A - GTIN 00195278576460; ONE-A2-1B - GTIN 00195278573797; ONE-A1-1B-L - GTIN 00195278573780; ONEA2-2A - GTIN 00195278576477; ONE-A2-2A-L GTIN 00195278576484; ONE-A3-1B - GTIN 00195278573810; ONE-A3-2A - GTIN 00195278576491; ONE-P1-1B - GTIN 00195278573834; ONE-P1-2A - GTIN 00195278576507; ONE-P2-1B - GTIN 00195278573827; and ONE-P2-2A - GTIN 00195278576514.
Root Cause
Under Investigation by firm
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.