Ultracell Wick with 80cc Collection Bag, 20/box
FDA Recall Z-1199-2023 · Posted 2023-03-01
Recalling FirmBeaver Visitec International, Inc.
Recall StatusOpen, Classified
Product CodeHOZ
Date Initiated2022-12-20
Product Quantity4640 units in total
Reason for Recall
Device packaging may contain open seals, compromising product sterility.
Firm 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].
Root Cause
Process control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.