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Open, Classified

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

FDA Recall Z-1658-2025 · Posted 2025-04-23

Recalling FirmEdge Biologicals Inc
Recall StatusOpen, Classified
Product CodeQMC
Date Initiated2023-10-02
Product Quantity660 units

Reason for Recall

Due to product outer packaging incorrectly labeled.

Firm Action

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 [email protected] 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 [email protected] / Phone 901-523-0034 or FAX 901-527-3343, or Consultant at [email protected] / Phone 858-880-6635

Root Cause

Labeling mix-ups

Distribution Pattern

U.S. Nationwide distribution in the state of PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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