Z-1554-2022 Class II Ongoing
FDA device recall Z-1554-2022 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: 850 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 24, 2022
- Initiation Date
- Jul 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 850 units
Product Description
NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
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-0701; Lots: 22027483172 and 22131487071 UDI/DI: M752ZZ07010
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1554-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026