🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: April 9, 2024 GE Medical Systems Information Technologies Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Medical Systems Information Technologies Inc
Reason for Recall:
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2027-2024

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