FDA Medical Device Recalls (openFDA)
Galil Medical: 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.
- Recall number
- Z-1698-2008
- Recalling firm
- Galil Medical
- 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.
- Status
- Terminated
- Initiated
- 2007-12-11
- Posted
- 2008-09-03
- Terminated
- 2008-09-02
- Reason
- The warming catheter was manufactured with the inlet and outlet tubes switched.
- 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
- 541 catheters
- Distribution
- Worldwide Distribution --- USA including states of PA, SC, FL, NY, TN, and WA, and country of Canada
- Lot, serial or model codes
- Catalog number ASMCH0340 sold within kits with the following part numbers: FPRPR4570, FPRPR4508, FPRPR3008, FPRPR4070, FPRPR353, and FPRPR4003.
- 510(k) numbers
- ["K012497"]
- PMA numbers
- not on file
- Product code
- GEH
- Firm FEI
- 3004462490
- Firm city
- Plymouth Meeting
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28