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Recall Observatory FDA recall evidence

Device product

Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.

Z-2227-2024

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-2227-2024

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 #DYNJ38429D containing component 65945 - lot numbers 23JMF534, exp. 12/31/2024, 23JMC032, exp. 5/31/2024, 23HMD025, exp. 5/31/2024, and 23GMC207, exp. 5/31/2024. Pack #DYNJ38429D containing component 67645 - lot number 23HMH776, exp. 5/31/2024.

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