Civco Needle Guide Recall Due to Missing or Inadequate Adhesive
Civco Medical Instruments is recalling 3 units of CIVCO Needle Guides because missing or inadequate adhesive may fail to hold the cannula in place.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, a Class II recall without explicit reports of hospitalization or significant injury falls into the 'High' category, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling 3 units of CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO. The recall involves specific units identified by UDI 00841436107334 and Lot numbers A035054 and A042207.
The recall was initiated because the assembly of the needle guides was found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide. This defect could compromise the stability of the device during use.
The affected products were distributed in the United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland, and the United Kingdom. Users should check their inventory for the specific lot numbers and UDI listed above and stop using the affected units.
The recalled product
- Product
- CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Category
- Medical Device — Needle Guide
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI 00841436107334
- Lot numbers: A035054
- A042207
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Civco Medical Instruments Co. Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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