Z-1497-2023Class II

CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic...

Name: Z-1497-2023 CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic...
Creator: Beaver Visitec International, Inc.
Published: 2023-03-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2023-03-17 / Open, Classified

FDA source

Beaver Visitec International, Inc. began a recall of CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be... on 2023-03-17. FDA classified it as Class II and gives the reason as "Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1497-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-17
Posted: 2023-05-02
Recalling firm: Becton Dickinson & Co
Product: CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01
Product code: HPS Unit, Cryophthalmic
Reason for recall: Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure.
FDA root cause: Under Investigation by firm
Action: Beaver Visitec in conjuction with (Vitreq B.V.) issued Urgent Medical Device Recall letter CryoTreq REF# CT00.D01-Voluntary recall of affected lots, on 3/17/23 via Certified Mail. Letter states reason for recall, health risk and action to take: 1. Stop using any CryoTreq IMMEDIATELY. Examine your inventory and quarantine product from all lots subject to this voluntary recall. 2. If you have further distributed this product, please identify your customers and notify them of this voluntary product recall. Consider all potential users of this product in your user supply chain. Please provide them with a copy of the present Field Safety Notice. 3. Complete the Attachment 1: Response Form enclosed IMMEDIATELY, as evidence of the product being returned, and we will credit your account OR complete the response form even if you do not have product to return. 4. Return the Attachment 1: Response Form by e-mail to: [email protected] 6. Return ALL quarantined product from the affected lots to our company via pre-paid postal labels, which will be supplied to you by our recall team. If you need further assistance, you can contact us using the information below. Email: [email protected] Phone: 877-870-4486 Credit will be provided to consignees who have replied with confirmation of receiving affected product. Please include in the subject line: Master Case PIR 00424262. Please direct any questions regarding credit to our customer service department by email [email protected]
Quantity in commerce: 501 (USA)
Distribution: US Nationwide distribution.
Product codes and lots: GTIN: 08719214223458 All Affected Lots: 20214450, 20214366, 20214367, 20214518, 20214522, 20214615, 20214744, 20214745, 20214961, 20214962, 20215203, 20215204, 20215479, 20216263, 20216264, 20216010, 20227952, 20227950, 20227951, 20228408, 20228657, 20228897, 20228898, 20229034, 20229138, 20229334, 20229460, 20229630, 20229748, 20230261, 20221083, 20221140, 20221364, 20221746, 20221894, 20222365

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1497-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1497-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-10	2023-05-02

Product code HPS

K202038Class IICryoTreQVitreQ BV / cleared 2020-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)