Z-1199-2023Class II

Ultracell Wick with 80cc Collection Bag, 20/box

Name: Z-1199-2023 Ultracell Wick with 80cc Collection Bag, 20/box
Creator: Beaver Visitec International, Inc.
Published: 2022-12-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2022-12-20 / Open, Classified / root cause: manufacturing process

FDA source

Beaver Visitec International, Inc. began a recall of Ultracell Wick with 80cc Collection Bag, 20/box on 2022-12-20. FDA classified it as Class II and gives the reason as "Device packaging may contain open seals, compromising product sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1199-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-20
Posted: 2023-03-01
Recalling firm: Becton Dickinson & Co
Product: Ultracell Wick with 80cc Collection Bag, 20/box
Product code: HOZ Sponge, Ophthalmic
Reason for recall: Device packaging may contain open seals, compromising product sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to [email protected].
Quantity in commerce: 4640 units in total
Distribution: US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa
Product codes and lots: Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1199-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1199-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01
Z-1200-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01

Product code HOZ

K920354Class IIOphthalmic SpongesUltracell Medical Technologies, Inc. / cleared 1992-08-05

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)