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Recall Observatory FDA recall evidence

Device product

Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED

Z-1049-2024

December 04, 2023

Class I

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 93551
Status
Ongoing
Classification
Class I
Quantity
63360 units
Official record key
device-enforcement:Z-1049-2024

Official wording

Reason: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

Code information: 66820, Lot Numbers: 2217401764, 2305706564, 2200426764, 2201121964, 2212328164, 2213015364, 2213709164, 2215108864, 2232203764, 2312920864, 2313507064

Distribution pattern: US and EMEA, Japan, Latin America

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.