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,

Hazard

Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.

Details from the source

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. Quantity: 23,180/20-cuff boxes 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.

UPC codes

00195278573803, 00195278576460, 00195278573797, 00195278573780, 00195278576477, 00195278576484, 00195278573810, 00195278576491, 00195278573834, 00195278576507, 00195278573827, 00195278576514

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.