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U.S. Department of Health and Human Services

Class 2 Device Recall Ultracell

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  Class 2 Device Recall Ultracell see related information
Date Initiated by Firm December 20, 2022
Date Posted March 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-1199-2023
Recall Event ID 91488
510(K)Number K920354  
Product Classification Sponge, ophthalmic - Product Code HOZ
Product Ultracell Wick with 80cc Collection Bag, 20/box
Code Information Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123
Recalling Firm/
Manufacturer		 Beaver Visitec International, Inc.
500 Totten Pond Rd
10 City Point
Waltham MA 02451-1916
For Additional Information Contact Ms. Aminah Crawford
781-906-7950
Manufacturer Reason
for Recall		 Device packaging may contain open seals, compromising product sterility.
FDA Determined
Cause 2		 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 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HOZ and Original Applicant = ULTRACELL MEDICAL TECHNOLOGIES, INC.
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