Z-0159-2023 Class II Ongoing
FDA device recall Z-0159-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Sep 30, 2022 and is designated Class II. Reason for recall: Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. The recall status is ongoing. Affected quantity: 16 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 9, 2022
- Initiation Date
- Sep 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 kits
Product Description
BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.
Reason for Recall
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Distribution Pattern
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Code Information
GTIN (010 10889942352920, Lot Number 22DBN366
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0159-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026