Z-1553-2022 Class II Ongoing
FDA device recall Z-1553-2022 was initiated by Stradis Medical, LLC Dba Stradis Healthcare on Jul 25, 2022 and is designated Class II. Reason for recall: The sterile barrier may be compromised. The recall status is ongoing. Affected quantity: 825 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 24, 2022
- Initiation Date
- Jul 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 825 units
Product Description
NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Reason for Recall
The sterile barrier may be compromised.
Distribution Pattern
US Nationwide distribution in the state of SC.
Code Information
SKU/Part Number: ZZ-0700; Lots: 22145487092 and 22154486659 UDI/DI: M752ZZ07000
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1553-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026