CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235,
FDA device recall Z-0286-2016 · posted 2015-11-17 · Terminated
Recall details
- Recalling firm
- Civco Medical Instruments Co. Inc.
- Reason for recall
- Sterility of the product cannot be assured.
- Action taken
- Civco Medical Solutions sent an Urgent Medical Device Recall letter dated October 19, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected needle guides. If the needle guide is contained within a kit, only the needle guide from the kit needs to be returned. The communication contains a response form to be completed and returned by the customer. The customer filling out the response form is asked to acknowledge receipt of the recall notice and indicate the number and type of affected product they are returning. Customers withh questions were instructed to call 800-445-6741 or 319-248-6757 or email order@civco.com. For questions regarding this recall call 319-248-6502.
- Root cause
- Process design
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 717 boxes
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY
- Date initiated
- 2015-10-21
- Date posted
- 2015-11-17
- Date terminated
- 2017-02-28
- Location
- Kalona, IA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM (K093713) | Civco Medical Instruments | 2010-01-19 |