FDAClass IIFebruary 15, 2023

Sterile Procedural Trays recall

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.…

Why was Sterile Procedural Trays recalled?

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
260 cases (1,200 units)
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Recall date
February 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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