GE HealthCare CRITIKON ONE-CUF blood pressure cuffs may give inaccurate readings
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs may provide inaccurate measurements. The FDA recalls approximately 23,180 boxes distributed across 20 US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II device recall for blood pressure cuffs that could provide inaccurate measurements. No injuries have been reported, but the potential for inaccuracy in a critical medical device represents a risk-of-harm product that meets the threshold for a High severity rating.
Plain-English summary
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs are being recalled due to the potential for inaccurate non-invasive blood pressure measurements. The product is available in 12 different models, covering sizes for infants, children, and adults, with two types of connectors.
Approximately 23,180 boxes containing 20 cuffs each were distributed in 20 US states: Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, Tennessee, and Texas. The cuffs can be identified by their model numbers and associated GTIN codes.
Inaccurate blood pressure measurements could lead to incorrect patient management decisions. Healthcare facilities using these cuffs should take appropriate action regarding their inventory.
The recalled product
- Product
- 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…
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Category
- Medical Device
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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.
Distribution
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