CLASS II ONGOING Device recall · Reported 25 May 2022 · FDA Enforcement Report
Vitriguard, Carrier, Clear recalled by CooperSurgical
CooperSurgical is recalling Vitriguard, Carrier, Clear, distributed in 10 states. The recall was initiated on 1 Apr 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1108-2022
- FDA event ID
- 90042
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Apr 2022
- FDA classified
- 17 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 1 Apr 2022 | Recall initiated by company | |
| 17 May 2022 | Classified by FDA | +46 days |
| 25 May 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Where it was distributed
Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
ArizonaCaliforniaFloridaIllinoisMichiganMissouriNew YorkOregonTexasWest Virginia
Questions about this recall
Why was it recalled?
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
Which lots are affected?
GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796 Lot 264453
Where was it sold?
Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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