Colonoscope Product Usage: Intended to provide optical recall
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy…
Why was Colonoscope Product Usage: Intended to provide optical recalled?
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
EC-3430L, EC-3430LK, EC-3470LK, EC-380LKP, EC-3830LK, EC-3830LZ, EC-3831L, EC-3832L, EC-3832LK, EC-3870LK, EC-3870LZK, EC-3872LK, EC-3830TLK, EC-3832TL, EC-3870TLK, EC-3872TLK, EC-3440L, EC-3840L, EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC34-I10L, EC-3890LI, EC-3890LK, EC-3890TLK, EC38-I10L and FC-38LV.
- Product
- Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy…
- Recalling firm
- Pentax Medical Company
- Quantity
- 12,412 units
- Distribution
- US Nationwide Distribution
- Recall date
- August 3, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)