Edge 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
This recall is currently active, issued April 23, 2025. It was issued by Edge Biologicals Inc.
- Company
- Edge Biologicals Inc
- Recall Initiated
- October 2, 2023
- Posted
- April 23, 2025
- Recall Number
- Z-1658-2025
- Quantity
- 660 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Due to product outer packaging incorrectly labeled.
Distribution
U.S. Nationwide distribution in the state of PA.
Lot / Code Info
Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223
Root Cause
Labeling mix-ups
Action Taken
On 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