Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usage: Galil Medicals 17G Cryoabl
FDA device recall Z-1613-2012 · posted 2012-05-16 · Terminated
Recall details
- Recalling firm
- Galil Medical, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- GEH
- Quantity affected
- 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.
- Date initiated
- 2012-04-12
- Date posted
- 2012-05-16
- Date terminated
- 2012-08-16
- Location
- Arden Hills, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS (K060144) | Galil Medical , Ltd. | 2006-02-13 |