FDAFDA · Food and drugs·Recall number Z-2227-2024
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.
Published July 10, 2024 · Recall initiated: March 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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