Reported Jun 13, 2018 · Terminated
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained…
Hobbs Medical, 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: Hobbs Medical, Inc. · 8 Spring St · Stafford Springs, CT · 06076-1505
Is this the product you have?
- Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
- Lot codes and dates
H07-17-157H12-17-004H10-17-055H12-17-062H11-17-101H12-17-062H11-17-119H12-17-064H11-17-120H12-17-064H11-17-121H12-17-065H11-17-122H12-17-066H11-17-123H12-17-067H11-17-124H01-18-095H11-17-125H01-18-096H11-17-126H01-18-097H11-17-127H01-18-097H11-17-128H01-18-098H11-17-129H01-18-098H11-17-130H01-18-098H12-17-002H01-18-099H12-17-003H01-18-100H12-17-003H01-18-101H01-18-102
- Amount recalled
- 1820 devices
Where it was sold
Why it was recalled
Device was marketed for uses outside the 510(k) clearance.
This product could cause temporary or reversible health problems — stop using it.
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