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Terminated

Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box.

FDA Recall Z-0977-03 · Posted 2003-08-26

Recalling FirmWatson Diagnostics Inc.
Recall StatusTerminated
Product CodeMPU
Date Initiated2003-08-07
Date Terminated2007-12-14
Product Quantity662 boxes

Reason for Recall

Lights split, spilling contents when bent to activate.

Firm Action

Users are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963391SPECULITETrylon Corp. · 1997-12-12

Official Source

View FDA Recall →

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

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