FDA Medical Device Recalls (openFDA)
Beaver Visitec International, Inc.: Ultracell Wick with 80cc Collection Bag, 20/box
- Recall number
- Z-1199-2023
- Recalling firm
- Beaver Visitec International, Inc.
- Product
- Ultracell Wick with 80cc Collection Bag, 20/box
- Status
- Open, Classified
- Initiated
- 2022-12-20
- Posted
- 2023-03-01
- Terminated
- not on file
- Reason
- Device packaging may contain open seals, compromising product sterility.
- 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 beavervisitec8978@sedgwick.com.
- Quantity
- 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
- Lot, serial or model codes
- Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123
- 510(k) numbers
- ["K920354"]
- PMA numbers
- not on file
- Product code
- HOZ
- Firm FEI
- 1211998
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28