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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Water, 3mL, 10/PK

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 Class 2 Device Recall Sterile Water, 3mL, 10/PKsee related information
Date Initiated by FirmOctober 02, 2023
Date PostedApril 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1658-2025
Recall Event ID 96497
Product Classification Transport medium, notified per the VTM guidance - Product Code QMC
ProductEdge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
Code Information Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223
FEI Number 1049818
Recalling Firm/
Manufacturer		 Edge Biologicals Inc
598 N 2nd St
Memphis TN 38105-1634
For Additional Information ContactWalter C. Edge III
901-523-0034
Manufacturer Reason
for Recall		Due to product outer packaging incorrectly labeled.
FDA Determined
Cause 2		Labeling mix-ups
ActionOn 10/02/2023, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that Edge Biologicals, Inc. is voluntarily recalling Sterile Water, Catalogue Number T-0780, Lot # 01223 due to the product being mislabeled as T-0627 Sterile Saline 85%. Customers are instructed to located any affected products, stop use and quarantine products until it is able to be returned to Edge Biologics, Inc. Use the following procedures to obtain a Return Merchandise Authorization (RMA): -Send a request per communication to qc@edgebiological.com titled: RMA requested for 1049818/10022023/R1 -Call 901-523-0034 and request an RMA reference: 1049818/10022023/R1 For Questions, contact Edge Biologicals team members: QC Manager/Microbiologist at qc@edgebiological.com / Phone 901-523-0034 or FAX 901-527-3343, or Consultant at mmedina@novaremedical.com / Phone 858-880-6635
Quantity in Commerce660 units
DistributionU.S. Nationwide distribution in the state of PA.
Total Product Life CycleTPLC 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.
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