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Recall Observatory FDA recall evidence

Device product

Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)

Z-0465-2025

October 21, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95671
Status
Ongoing
Classification
Class II
Quantity
69,611
Official record key
device-enforcement:Z-0465-2025

Official wording

Reason: Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.

Code information: UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787

Distribution pattern: US Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS, LA, MA, MO, NC, NY, OK, OR, RI, TN, TX, VA, WA, WY.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility