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U.S. Department of Health and Human Services

Class 2 Device Recall OnGuard2 CSTD Bag Adaptor SP

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  Class 2 Device Recall OnGuard2 CSTD Bag Adaptor SP see related information
Date Initiated by Firm March 08, 2022
Create Date May 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-1057-2022
Recall Event ID 89952
510(K)Number K192866  
Product Classification Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
Product OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Code Information UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536
Recalling Firm/
Manufacturer		 SIMPLIVIA HEALTHCARE LTD.
NORTH IND. ZONE, (MIGADA PLANT)
NORTH IND. ZONE PoBOX 888
Kiryat Shmona Israel
Manufacturer Reason
for Recall		 Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
FDA Determined
Cause 2		 Equipment maintenance
Action The recall notice and acknowledgement form dated 08 March 2022 were sent under B. Braun cover letter on 03/10/2022 via Certified USPS mail. Distributors are to forward the recall notification to customers to extend the recall to the end user/customer level. Identify current inventory, cease use and quarantine product subject to recall. Do not destroy, return product and complete the Product Removal Acknowledgement form. If you are a direct consignee of B. Braun Medical Inc. a B. Braun customer service representative will contact you to arrange for return of product. If you have received this recall notice from a customer of B. Braun, please return product to your local distributor to ensure proper credit and replacement of material. OnGuard Spike Port Adaptor may be used as an alternative to replace the OnGuard2 Bag Adaptor SP. If you have questions contact Simplivia: Shay Shaham, Sunday to Friday, 08:00 to 19:00 (GMT+2) at the following phone number: 97246908826.
Quantity in Commerce 293,520
Distribution Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.
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 = ONB and Original Applicant = Simplivia Healthcare Ltd.
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