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Terminated

CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305

FDA Recall Z-1235-03 · Posted 2003-09-13

Recalling FirmBlue Torch Medical Technologies
Recall StatusTerminated
Date Initiated2003-07-10
Date Terminated2003-10-22
Product Quantity20 units

Reason for Recall

Product's sterility is compromised due to a failed sterility audit

Firm Action

Blue TorchMedical notified 2 consignees by fax on 7/10/03, requesting return of unused inventory.

Root Cause

Other

Distribution Pattern

NY, TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000507CAVERMAP SURGICAL AIDUromed Corp. · 2000-04-21K993436CAVERMAP SURGICAL AIDUromed Corp. · 2000-02-11

Official Source

View FDA Recall →

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

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