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Recall Observatory FDA recall evidence

Device product

Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.

Z-2225-2024

March 14, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94239
Status
Ongoing
Classification
Class II
Quantity
12,588 total sterile kits
Official record key
device-enforcement:Z-2225-2024

Official wording

Reason: Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information: Pack #DYNJ47873L - lot numbers 23KBW512, exp. 8/31/2027, UDI-DI each-10195327506896, UDI-DI case-40195327506897.

Distribution pattern: US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach in sterility