Z-1095-2023 Class II Ongoing
FDA device recall Z-1095-2023 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: 260 cases (1,200 units).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 15, 2023
- Initiation Date
- Nov 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 260 cases (1,200 units)
Product Description
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLOGY PACK l. OCULOPLASTIC PACK m. BLEPH PACK n. EYE PACK o. OCULAR PLASTIC PACK p. OCULOPLASTIC PACK
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. BASIC EYE PACK-LF, Item Number: DYNJ0842521C, Case UDI/GTIN: 40193489352383, Unit UDI/GTIN: 10193489352382, Lot Number: 22JDA005,22HDC265; b. VITRECTOMY PACK-LF, Item Number: DYNJ0843936F, Case UDI/GTIN: 40193489352390, Unit UDI/GTIN: 10193489352399, Lot Number: 22JDA822,22IDB984; c. EYE PACK-EAST-LF, Item Number: DYNJ14064, Case UDI/GTIN: 40080196931102, Unit UDI/GTIN: 10080196931101, Lot Number: 22JBC143,22IBF606; d. OSC OCULAR PLASTIC PACK-LF, Item Number: DYNJ31639B, Case UDI/GTIN: 40889942292067, Unit UDI/GTIN: 10889942292066, Lot Number: 22JBG389,22HBY420; e. EYE PACK, Item Number: DYNJ35056A, Case UDI/GTIN: 40889942227564, Unit UDI/GTIN: 10889942227563, Lot Number: 22JBL816; f. OCULOPLASTIC PACK, Item Number: DYNJ46539J, Case UDI/GTIN: 40193489997355, Unit UDI/GTIN: 10193489997354, Lot Number: 22JME546,22JME931; g. EYE PLASTIC PACK, Item Number: DYNJ47859C, Case UDI/GTIN: 40193489916066, Unit UDI/GTIN: 10193489916065, Lot Number: 22JBS972; h. PLASTIC EYE PACK, Item Number: DYNJ49413A, Case UDI/GTIN: 40888277971593, Unit UDI/GTIN: 10888277971592, Lot Number: 22KBA929; i. DR H BLEPH PACK, Item Number: DYNJ54487A, Case UDI/GTIN: 40193489587877, Unit UDI/GTIN: 10193489587876, Lot Number: 22HBG403; j. BLEPH PACK, Item Number: DYNJ62174A, Case UDI/GTIN: 40195327037780, Unit UDI/GTIN: 10195327037789, Lot Number: 22IBT956; k. OPHTHALMOLOGY PACK, Item Number: DYNJ63785, Case UDI/GTIN: 40193489760744, Unit UDI/GTIN: 10193489760743, Lot Number: 22IBN397; l. OCULOPLASTIC PACK, Item Number: DYNJ66365, Case UDI/GTIN: 40193489346627, Unit UDI/GTIN: 10193489346626, Lot Number: 22JBE699; m. BLEPH PACK, Item Number: DYNJ67875, Case UDI/GTIN: 40193489448826, Unit UDI/GTIN: 10193489448825, Lot Number: 22JBY558,22JBY531; n. EYE PACK, Item Number: DYNJ69446, Case UDI/GTIN: 40193489942546, Unit UDI/GTIN: 10193489942545, Lot Number: 22IBS350,22HBN241; o. OCULAR PLASTIC PACK, Item Number: DYNJ82588, Case UDI/GTIN: 40195327198795, Unit UDI/GTIN: 10195327198794, Lot Number: 22HBJ348; p. OCULOPLASTIC PACK, Item Number: DYNJ908778, Case UDI/GTIN: 40195327177660, Unit UDI/GTIN: 10195327177669, Lot Number: 22JBW843
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1095-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026