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Terminated

Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008

FDA Recall Z-1132-2008 · Posted 2008-05-22

Recalling FirmKeeler Instruments Inc
Recall StatusTerminated
Product CodeHLI
Date Initiated2008-01-08
Date Terminated2008-08-12
Product Quantity25 units

Reason for Recall

Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.

Firm Action

Keeler Instruments issued an email dated 1/8/08 to the distributor requesting that they return the product.

Root Cause

Process design

Distribution Pattern

The products were shipped to a distributor in NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K854244THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPEKeeler Instruments, Inc. · 1985-11-12

Official Source

View FDA Recall →

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

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