Z-1613-2012

Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO

Name: Z-1613-2012 Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO
Creator: Galil Medical, Inc.
Published: 2012-04-12
License: https://open.fda.gov/license/

Galil Medical Ltd. / initiated 2012-04-12 / Terminated / root cause: manufacturing process

FDA source

Galil Medical, Inc. began a recall of Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usage: Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is... on 2012-04-12. The reason FDA records is "Galil Medical is recalling 17G Cryoablation Needle Holder, FPRPR 4014. This voluntary recall has been initiated due to the possibility of excessive bioburden on the Needle Holders". 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-1613-2012
Status: Terminated
Initiated: 2012-04-12
Posted: 2012-05-16
Terminated: 2012-08-16
Recalling firm: Galil Medical Ltd.
Product: Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usage: Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure, and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment, prior to use.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Galil Medical is recalling 17G Cryoablation Needle Holder, FPRPR 4014. This voluntary recall has been initiated due to the possibility of excessive bioburden on the Needle Holders.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Galil Medical sent an "Urgent Medical Device Recall" letter dated April 12, 2012 to all affected customers. The letter identified the affected product, problem, actions to be taken. The letter instructs customers to return all unused affected products, use a revised needle preparation procedure and forward and communicate this Recall Notice and instructions. Customers were instructed to complete and return the attached Response Form with returned product or fax to 1+877-510-7757. For any questions contact Galil Medical Customer Service.
Quantity in commerce: 26 kits
Distribution: Worldwide Distribution - USA (nationwide) including the states of CA, NY, NC, WA and the countries of CANADA, DENMARK, FRANCE, NETHERLANDS, TAIWAN and UNITED KINGDOM.
Product codes and lots: N8185-001; N9438-001; N9438-003; N9438-004; N7890-003; N7975-001; N7975-002; N8185-006; N8185-007; N7729-005; N7890-004; N9438-002; N8185-005; N8185-008; N7890-005; N7975-003; N7729-001; N7729-002; N8185-009; N8185-010; N7729-003; N7729-004; N7890-001; N7890-002 ; N7975-004;N7975-005

Product code GEH

K060144Class IISeednet/seednetgold, Cryothera and Cryo-Hit SystemsGalil Medical , Ltd. / cleared 2006-02-13

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)