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
Product summary
- 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
breach in sterility