Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
FDA Recall Z-2107-2025 · Posted 2025-07-10
Advertisement
Recalling FirmPreat Corp
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2025-06-24
Product Quantity44 units
Reason for Recall
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Firm Action
On June 24, 2025 Preat Corporation issued a "Urgent: Medical Device Recall" to affected consignees via certified mail. Preat asked consignees to take following actions:
1. Immediately review your inventory for product listed in the table below.
2. Customers shall stop/cease use of the product in the scope of this recall.
3. It shall be discarded or returned to PREAT CORPORATION. Instructions for the return will be provided.
4. All personnel within your company should be made aware of the issue. Any customers to which this product has been further distributed should be provided a copy of this notification and informed to notify their customers.
5. Complete and return the Customer Response Form following completion of your reconciliation activities.
Root Cause
Employee error
Distribution Pattern
US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement