Z-1698-2008

Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This...

Name: Z-1698-2008 Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This...
Creator: Galil Medical
Published: 2007-12-11
License: https://open.fda.gov/license/

Galil Medical Ltd. / initiated 2007-12-11 / Terminated / root cause: manufacturing process

FDA source

Galil Medical began a recall of Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing... on 2007-12-11. The reason FDA records is "The warming catheter was manufactured with the inlet and outlet tubes switched". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1698-2008
Status: Terminated
Initiated: 2007-12-11
Posted: 2008-09-03
Terminated: 2008-09-02
Recalling firm: Galil Medical Ltd.
Product: Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing of tissue.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: The warming catheter was manufactured with the inlet and outlet tubes switched.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm telephoned their customers in April 2008 to inform them of the problem and the need to return the product. There customers were also asked to contact the firm if they had actually used any of the kits with the serial numbers listed, even if they experienced no problem. As a follow up to the telephone call, a letter was issued to the customers. For assistance, please call 770-565-6166.
Quantity in commerce: 541 catheters
Distribution: Worldwide Distribution --- USA including states of PA, SC, FL, NY, TN, and WA, and country of Canada
Product codes and lots: Catalog number ASMCH0340 sold within kits with the following part numbers: FPRPR4570, FPRPR4508, FPRPR3008, FPRPR4070, FPRPR353, and FPRPR4003.

Product code GEH

K012497Class IICryo-Hit, Models Ep6t5, Fp5t5, Fp5t3, Ep2t2, Ep1t1, and Ep2t1Galil Medical , Ltd. / cleared 2001-10-30

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)