Reported Jun 12, 2024 · Ongoing
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET,…
GE Medical Systems Information Technologies Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems Information Technologies Inc · 9900 W Innovation Dr · Milwaukee, WI · 53226-4856
Is this the product you have?
12 of 12 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
12 of 12 products
Products covered by this recall Model / number Barcodes Product as published 00195278573803No serial numbers are on the blood pressure cuffs. GTIN NUMBERS: ONE-A1-1B 00195278576460ONE-A1-2A 00195278573797ONE-A2-1B 00195278573780ONE-A1-1B-L 00195278576477ONEA2-2A 00195278576484ONE-A2-2A-L 00195278573810ONE-A3-1B 00195278576491ONE-A3-2A 00195278573834ONE-P1-1B 00195278576507ONE-P1-2A 00195278573827ONE-P2-1B 00195278576514.00195278576514and ONE-P2-2A - Amount recalled
- 23,180/20-cuff boxes
Where it was sold
Why it was recalled
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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