FDA-Device2023-02-15Class II
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
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Affected count
260 cases (1,200 units)
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1095-2023Don't want to check this manually?
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