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Terminated

Video Duodenoscope

FDA Recall Z-1835-2016 · Posted None

Recalling FirmPentax Medical Company
Recall StatusTerminated
Product CodeFDT
Date Initiated2016-02-22
Date Terminated2017-12-06
Product Quantity423 units

Reason for Recall

Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

Firm Action

Pentax Inc. issued an "Urgent Field Correction" Letter dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter provides information regarding the updated Reprocessing instruction for use along with some main changes in the Operation IFU. Instructions are also provided regarding prior versions of the Reprocessing and Operation Instructions for Use. A web posting went live on 2/19/2016. For further questions, please call: Tel:800-431-5880 ext. 2064 (8:30AM- 5:00 PM, Monday-Friday, EST)

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092770SIMPLYGO HANDS FREE BREAST PUMPEvenflo Company, Inc. · 2009-10-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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