PlainRecalls
FDA Devices Moderate Class II Terminated

CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO

Reported: September 5, 2018 Initiated: July 30, 2018 #Z-2946-2018

Product Description

CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO

Reason for Recall

The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.

Details

Units Affected
107 units
Distribution
United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
Location
Kalona, IA

Frequently Asked Questions

What product was recalled?
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO. Recalled by Civco Medical Instruments Co. Inc.. Units affected: 107 units.
Why was this product recalled?
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2946-2018.