Z-1235-03

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

Name: Z-1235-03 CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305
Creator: Blue Torch Medical Technologies
Published: 2003-07-10
License: https://open.fda.gov/license/

Blue Torch Medical Technologies / initiated 2003-07-10 / Terminated / root cause: sterility

FDA source

Blue Torch Medical Technologies began a recall of CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305 on 2003-07-10. The reason FDA records is "Product's sterility is compromised due to a failed sterility audit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1235-03
Status: Terminated
Initiated: 2003-07-10
Posted: 2003-09-13
Terminated: 2003-10-22
Recalling firm: Blue Torch Medical Technologies
Product: CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305
Reason for recall: Product's sterility is compromised due to a failed sterility audit
Root cause tag: sterility
FDA root cause: Other
Action: Blue TorchMedical notified 2 consignees by fax on 7/10/03, requesting return of unused inventory.
Quantity in commerce: 20 units
Distribution: NY, TX
Product codes and lots: Lot Number: JCQ3141 EXpiration Date:May 2004

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)