Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic acces...

FDA Device Recall #Z-2275-2016 — Class II — April 6, 2016

Recall Summary

Recall Number Z-2275-2016
Classification Class II — Moderate risk
Date Initiated April 6, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pentax Medical Company
Location Montvale, NJ
Product Type Devices
Quantity 12,412 units

Product Description

Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Reason for Recall

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.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

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.

Other Recalls from Pentax Medical Company

Recall # Classification Product Date
Z-2280-2016 Class II Signmoidoscope Product Usage: Intended to p... Apr 6, 2016
Z-2065-2016 Class II Bronchoscope Intended to provide optical visua... Apr 6, 2016
Z-2068-2016 Class II Colonoscope Intended to provide optical visual... Apr 6, 2016
Z-2072-2016 Class II Intubation Scope Intended to provide optical v... Apr 6, 2016
Z-2276-2016 Class II Confocal GI Scope Product Usage: Intended t... Apr 6, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.