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Terminated

Conformer - Medium (Sterile)

FDA Recall Z-0535-03 · Posted 2003-02-05

Recalling FirmGulden Ophthalmics
Recall StatusTerminated
Product CodeHQX
Date Initiated2002-11-29
Date Terminated2004-02-06

Reason for Recall

lack of sterility assurance

Firm Action

The recalling firm issued letters to the accounts requesting the return of the devices.

Root Cause

Other

Distribution Pattern

Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972661EYE SPHERE, CONFORMERSGulden Ophthalmics · 1997-10-03

Official Source

View FDA Recall →

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

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