Vortex Surgical Inc.: 25GA Subretinal Injection Cannula VS0220.25

Company / brand

Vortex Surgical Inc.

Product

25GA Subretinal Injection Cannula VS0220.25

Reason / hazard

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

Classification

Class II

Status

Ongoing

Distribution / sold at

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.

Recall initiated

2025-12-16

Code info

Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043

Product quantity

14,789 (8651 US; 6138 OUS)

Voluntary mandated

Voluntary: Firm initiated

City

Saint Charles

State

MO

Country

United States

Event id

98255

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