Recall Z-1095-2023— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-11-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-17
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.