Z-1069-2023 Class II Ongoing
FDA device recall Z-1069-2023 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: 200 cases (858 units).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 15, 2023
- Initiation Date
- Nov 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 cases (858 units)
Product Description
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
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. BREAST BIOPSY PACK-LF, Item Number: DYNJ0160598B, Case UDI/GTIN: 40889942051930, Unit UDI/GTIN: 10889942051939, Lot Number: 22IDB852; b. BREAST BIOPSY PACK, Item Number: DYNJ45087C, Case UDI/GTIN: 40195327044764, Unit UDI/GTIN: 10195327044763, Lot Number: 22JBO180; c. LAPAROTOMY PACK, Item Number: DYNJ55654B, Case UDI/GTIN: 40193489956727, Unit UDI/GTIN: 10193489956726, Lot Number: 22JDA974; d. BREAST PACK, Item Number: DYNJ56546C, Case UDI/GTIN: 40195327231164, Unit UDI/GTIN: 10195327231163, Lot Number: 22JBE655; e. SOFT TISSUE PACK, Item Number: DYNJ68311, Case UDI/GTIN: 40193489821933, Unit UDI/GTIN: 10193489821932, Lot Number: 22JBL797,22GBV060; f. HEMORRHOID PACK, Item Number: DYNJ69404, Case UDI/GTIN: 40193489936620, Unit UDI/GTIN: 10193489936629, Lot Number: 22HBI624; g. RECTAL, Item Number: DYNJ901758G, Case UDI/GTIN: 40193489979696, Unit UDI/GTIN: 10193489979695, Lot Number: 22JBQ935; h. BREAST, Item Number: DYNJ905525C, Case UDI/GTIN: 40195327122943, Unit UDI/GTIN: 10195327122942, Lot Number: 22JMF862,22HMH312; i. BREAST, Item Number: DYNJ906000B, Case UDI/GTIN: 40195327092697, Unit UDI/GTIN: 10195327092696, Lot Number: 22IBR879;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1069-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026