Reported Jun 19, 2024 · Ongoing
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Covidien, LLC
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: Covidien, LLC · 3062 Bunker Hill Ln · Santa Clara, CA · 95054-1105
Is this the product you have?
- EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
- Lot codes and dates
- GTIN Number10884521809451/
- Lot
22K0854JZ23H0552JZ
- GTIN Number20884521809458/
- Lot
22E0781JZ22E0997JZ22I0422JZ22I0424JZ22I0425JZ22J1362JZ22K0743JZ22K0744JZ22K0745JZ22K0746JZ22K0854JZ23A0109JZ23A0111JZ23A1200JZ23A1201JZ23A1202JZ23C0144JZ23C0668JZ23C0669JZ23D0777JZ23D0778JZ23H0047JZ23H0552JZ23H0553JZ23H0554JZ23H0623JZ23H0624JZ23L0331JZ23L0338JZ23L0339JZ24A0014JZ24A0015JZ24B0392JZ
- Amount recalled
- N/A
Where it was sold
Why it was recalled
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
This product could cause temporary or reversible health problems — stop using it.
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