Z-1071-2023 Class II Ongoing
FDA device recall Z-1071-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Nov 17, 2022 and is designated Class II. Reason for recall: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. The recall status is ongoing. Affected quantity: 86 cases (152 units).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 15, 2023
- Initiation Date
- Nov 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86 cases (152 units)
Product Description
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Code Information
a. RHINOPLASTY PACK, Item Number: DYNJ27333F, Case UDI/GTIN: 40888277055293, Unit UDI/GTIN: 10888277055292, Lot Number: 22JMD960; b. OSC OTOLOGY PACK-LF, Item Number: DYNJ37384D, Case UDI/GTIN: 40193489306898, Unit UDI/GTIN: 10193489306897, Lot Number: 22HBY172; c. RHYZOTOMY, Item Number: DYNJ902288G, Case UDI/GTIN: 40193489885126, Unit UDI/GTIN: 10193489885125, Lot Number: 22JBU356,22JBT657;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1071-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026