FDAClass IISeptember 5, 2018

CIVCO Needle Guide recall

CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO

Why was CIVCO Needle Guide 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI 00841436107334, Lot numbers: A035054, A042207

Product
CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Recalling firm
Civco Medical Instruments Co. Inc.
Quantity
3 units
Distribution
United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
Recall date
September 5, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls