Civco recalls 24 sterile needle guides (REF 676-150) due to missing or weak adhesive causing assembly failure. Affected units have specific lot numbers and UDI.
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.
Civco is recalling 24 sterile needle guides that may have missing or insufficient adhesive, which could cause the cannula to detach during use. This poses a risk of injury if the needle guide becomes unstable while being used.
The needle guides may have missing or inadequate adhesive, causing the cannula to detach from the guide during use. This could lead to injury if the detached cannula moves unexpectedly.
Medical professionals using the needle guides for procedures are most at risk. Patients receiving these devices during medical treatments could be affected if the device fails.
Check for the product name 'Civco Needle Guide', model REF 6:676-150, and lot numbers A035054 or A042207. The unique device identifier (UDI) is 00841436107334.
Inspect the needle guide for signs of missing or weak adhesive holding the cannula in place.
The recall indicates the product may have missing or insufficient adhesive, which could cause detachment during use. Do not use until confirmed safe.
Look for the model REF 676-150 with lot numbers A035054 or A042207, and the unique device identifier (UDI) 00841436107334.
The recall does not specify a remedy, so check the device condition and contact Civco Medical Instruments Co. Inc. for further guidance.
We’ve drafted a message you can send Civco to request your refund or repair — edit it as you like.
Subject: Recall Z-2947-2018 — Civco Civco Hello, I own a Civco that is covered by recall Z-2947-2018 from Civco. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
