Recall Z-2065-2016
Pentax Medical Company · initiated April 6, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Codes / lots: Model #'s FB-10V, FB015BS, FB-15P, FB-15RBS, FB-15V, FB-18BS, FB-18P, FB-18RBS, FB-18V, FB-19TV, FB-8V, EB--1530T3, EB-1170K, EB01570K, EB-1575K, EB-1970K, EB-1970-TK and EB-1975K
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-2065-2016
- Initiated
- April 6, 2016
- Posted by FDA
- June 28, 2016
- Terminated
- December 21, 2017
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Quantity
- 4,195 units
- Distribution
- Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
- Recalling firm
- Pentax Medical Company, Montvale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2066-2016 Class II | Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2067-2016 Class II | Choledochoscope Intended to provide optical visualization of and therapeutic access to…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2068-2016 Class II | Colonoscope Intended to provide optical visualization of and therapeutic access to the…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2069-2016 Class II | Confocal GI Scope Intended to provide optical visualization of an therapeutic access to…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2070-2016 Class II | Cystoscope Intended to provide optical visualization of and therapeutic access to the…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2071-2016 Class II | Gastroscope Intended to provide optical visualization of and therapeutic access to the…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2072-2016 Class II | Intubation Scope Intended to provide optical visualization of, therapeutic access to…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2073-2016 Class II | Laryngo Stroboscope Product Usage Intended to provide optical visualization of…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2074-2016 Class II | Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2075-2016 Class II | Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2076-2016 Class II | Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2077-2016 Class II | Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2078-2016 Class II | Ureteroscope Intended to provide optical visualization of and therapeutic access to the…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2079-2016 Class II | Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |
| Z-2080-2016 Class II | Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | 04/06/2016Terminated |