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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

MEDLINE INDUSTRIES, LP - Northfield: Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Agency Publication Date: November 1, 2022
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Affected Products

Product: BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.

GTIN (01) 40195327061327, Lot Number 22DBM504

Lot Numbers:
Number
Product: BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.

GTIN (01) 40193489234405, Lot Number 22DBM505

Lot Numbers:
Number
Product: BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.

GTIN (01) 10889942336241, Lot Number 22DBN365

Lot Numbers:
Number
Product: BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.

GTIN (01) 40193489577540, Lot Number 22DBN862

Lot Numbers:
Number
Product: BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.

GTIN (010 10889942352920, Lot Number 22DBN366

Lot Numbers:
Number
Product: BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.

GTIN (01) 10889942339730, Lot Number 22DBM506

Lot Numbers:
Number
Product: BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.

GTIN (01) 10195327108168, Lot Number 22DBL466

Lot Numbers:
Number
Product: MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.

GTIN (01) 4019532701228, Lot Number 22DBL482

Lot Numbers:
Number
Product: MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.

GTIN (01) 40195327002535, Lot Number 22DBJ856

Lot Numbers:
Number
Product: MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.

GTIN (01) 40193489385404, Lot Number 22DBE139

Lot Numbers:
Number
Product: MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.

GTIN (01) 10195327027278, Lot Number 22OBK037

Lot Numbers:
Number
Product: MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.

UDI/DI (01) 40195327045471, Lot Number 22ABT774

Lot Numbers:
Number
Product: CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.

GTIN (01) 40653160316252, Lot Number 21KBB343

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90946
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Manufactured In: United States
Units Affected: 13 products (95 kits; 160 kits; 800 kits; 300 kits; 16 kits; 28 kits; 708 kits; 96 kits; 40 kits; 60 units; 240 kits; 50 kits; 50 kits)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.