Recall Z-2068-2016

Pentax Medical Company · initiated April 6, 2016

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Colonoscope 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.

Codes / lots: Model #'s EC-3430L, EC-3430LK, EC-3470LK, EC-380LKP, EC-3830LK, EC-3930LZ, EC-3831L, EC-3832L, EC-3832LK, EC-3870LK, EC-3870LZK, EC-3872LK, FC-38LV, EC-3830TLK, EC-3832TL, EC-3870TLK, EC-3872TLK, EC-3440L, EC-3840K, EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC34-I10L, EC-3890LI, EC-3890LK, EC-3890TLK and EC38-I10L

Reason for recall

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

FDA-determined cause: Device Design

Action taken

Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. Customers were instructed to contact their local PENTAX Medical Service facility to have the endoscope repaired. Customers with questions were instructed to call 800-431-5880, ext 2064.

Details

Recall number
Z-2068-2016
Initiated
April 6, 2016
Posted by FDA
June 28, 2016
Terminated
December 21, 2017
Product code
FDF – Colonoscope And Accessories, Flexible/Rigid
Quantity
12,412 units
Distribution
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Recalling firm
Pentax Medical Company, Montvale, NJ

Official FDA recall record

Other products in the same recall event

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