VitriGuard Cryopreservation Storage Device Recalled for Sterility Risk
CooperSurgical is recalling 2,340 VitriGuard cryopreservation devices with compromised barrier seals that may compromise sterility. The affected devices were distributed across ten U.S. states.
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: FDA Class II recall of a medical device with compromised barrier seals poses a sterility risk. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are scored at most 3 (High).
Plain-English summary
CooperSurgical, Inc. is recalling certain VitriGuard cryopreservation storage devices. The devices are used to store and preserve biological materials at extremely low temperatures.
The recalled devices may have compromised barrier seals that introduce a risk to sterility. The recall affects 2,340 devices in Lot 264453 distributed to healthcare facilities in Arizona, California, Florida, Illinois, Michigan, Missouri, New York, Oregon, Texas, and West Virginia.
Patients and healthcare providers should be aware of the potential sterility risk associated with these devices and should contact CooperSurgical, Inc. or their healthcare provider for guidance if they have received affected devices.
The recalled product
- Product
- VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 2,340
Distribution
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