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
- Recall Initiated
- November 17, 2022
- Posted
- February 6, 2023
- Recall Number
- Z-1095-2023
- Quantity
- 260 cases (1,200 units)
- Firm Location
- Northfield, IL
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
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Lot / Code Info
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
Root Cause
Device Design
Action Taken
Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.