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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Galil Medical
Lot Codes / Batch Numbers
Catalog number ASMCH0340 sold within kits with the following part numbers: FPRPR4570, FPRPR4508, FPRPR3008, FPRPR4070, FPRPR353, and FPRPR4003.
Products Sold
Catalog number ASMCH0340 sold within kits with the following part numbers: FPRPR4570, FPRPR4508, FPRPR3008, FPRPR4070, FPRPR353, and FPRPR4003.
Galil Medical is recalling Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kit due to The warming catheter was manufactured with the inlet and outlet tubes switched.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The warming catheter was manufactured with the inlet and outlet tubes switched.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, NY, PA, SC, TN, WA
Page updated: Jan 10, 2026