Z-0853-2020Class II

VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461

Name: Z-0853-2020 VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461
Creator: Vitreq Bv
Published: 2019-12-17
License: https://open.fda.gov/license/

Vitreq BV / initiated 2019-12-17 / Terminated / root cause: packaging

FDA source

Vitreq Bv began a recall of VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461 on 2019-12-17. FDA classified it as Class II and gives the reason as "Microscopic tears of the sterile pouch may compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0853-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-17
Posted: 2020-01-24
Terminated: 2020-12-09
Recalling firm: Vitreq BV
Product: VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461
Product code: HMX Cannula, Ophthalmic
Reason for recall: Microscopic tears of the sterile pouch may compromise sterility
Root cause tag: packaging
FDA root cause: Package design/selection
Action: VitreQ issued Urgent Medical Device recall dated 12/16/19 letter states reason for recall, health risk and action to take: 1.Immediately examine your inventory and quarantine product from all lots subject to recall. If you have further distributed this product, please identify your customers and notify them at once of this product recall. Consider all potential users of this product in your user supply chain. You may provide a copy of this recall notification letter; 2.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.3.Return the Attachment 1: Response Form to BVI by one of these methods: Fax 866-906-4304 or email a copy to [email protected]. If you have any specific product replacement questions you may contact Customer Service Team at: [email protected] or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).
Distribution: Nationwide
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0853-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0846-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0847-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0848-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0849-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0850-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0851-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0852-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0853-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0854-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0855-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0856-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0857-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0858-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0859-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0860-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24
Z-0861-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-24

Product code HMX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)