Z-2227-2024 Class II Ongoing
FDA device recall Z-2227-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 14, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 12,588 total sterile kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 10, 2024
- Initiation Date
- Mar 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,588 total sterile kits
Product Description
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.
Reason for Recall
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.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2227-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026