Z-1803-2015Class II

BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648...

Name: Z-1803-2015 BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648...
Creator: Beaver-Visitec International Inc.
Published: 2015-05-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2015-05-01 / Terminated / root cause: manufacturing process

FDA source

Beaver-Visitec International Inc. began a recall of BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits on 2015-05-01. FDA classified it as Class II and gives the reason as "Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1803-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-01
Posted: 2015-06-15
Terminated: 2021-01-28
Recalling firm: Becton Dickinson & Co
Product: BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beaver-Visitec International Sales Ltd. (BVI) sent an Urgent Field Safety Notice dated May 2, 2015, to all affected customers. Customers were instructed to quarantine the affected kits and return to BVI for subsequent replacement of product. A Verification Form was provided to confirm receipt of the recall notice. For questions regarding this recall call 791-906-7950.
Quantity in commerce: 384 kits
Distribution: Nationwide Distribution including KY, GA, MI, and NJ.
Product codes and lots: Lot Numbers: 3038787 3046210 3061080 3078492 3093681 3095940 3108668

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1803-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1802-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-15
Z-1803-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-15
Z-1804-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-15
Z-1805-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-15
Z-1806-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-15

Product code FSY

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)