Reported Dec 30, 2020 · Terminated
PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths,…
Prytime Medical Devices, 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: Prytime Medical Devices, Inc. · 229 N Main St · Boerne, TX · 78006-2035
Is this the product you have?
- PryTime Medical - ER-Reboa Plus Catheter
- RefER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only
- UDI(01) 0 0850001 10505 7 -
- Product Usageintended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage
- Lot codes and dates
- Lot # 205936
- Amount recalled
- 3 units
Where it was sold
- Nationwide
- UT
Why it was recalled
There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.
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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