Civco Medical Instruments Recalls CollectEVAC Sterile Devices Due to Packaging Leak
Civco Medical Instruments is recalling 52 kits of CollectEVAC sterile devices because a pinhole leak in the packaging could compromise sterility.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential compromise of sterility due to a packaging defect, which is a low-risk contamination issue without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Civco Medical Instruments Inc is recalling 52 kits of CollectEVAC sterile devices, part number 610-954. These devices are intended for irrigation, tissue collection, and straining during transurethral prostate or bladder surgery and are used with ACMI and STORZ/Wolf resectoscopes.
The recall was initiated because a pinhole leak was identified in the packaging, which potentially could compromise the sterility of the product. The affected lot numbers are M431760, M431710, M426580, M430200, and M423010.
The products were distributed worldwide, including in the United States (AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI) and internationally to Brazil. Healthcare providers should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate…
- Manufacturer
- Civco Medical Instruments Inc
- Affected units
- 52
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 (5)
- Lot numbers: M431760
- M431710
- M426580
- M430200
- M423010
Distribution
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