Reported Nov 24, 2021 · Ongoing
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
CooperSurgical, 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: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- Quantum 2000 Electrosurgical
- Generators Cooper Surgical Part Number909075-05
- Lot codes and dates
- Serial Numbers
648 of 648 codes
020900102090020209003020900402110010211002021100302110040211005021100602110070211008021100902110100211011021101202110130211014021101502110160211017021101802110190211020021102102110220211023021102402110250211026021102702110280211029021103002110310211032021103302110340211035021103602110370211038021103902110400215001021500202150030215004021500502150060215007021500802150090215010021501102150120215013021501402150150215016
- Serial Numbers
- Amount recalled
- 700 Units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
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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