RUMMELL, Medline Item No. ST006ST
FDA device recall Z-0760-2025 · posted 2024-12-23 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- Action taken
- On November 25, 2024, the firm notified customers via letters titled IMMEDIATE ACTION REQUIRED. Customers were informed that specific items and lots of Pure Pouch Single-Sterile and Sterile Kits are being recalled due to weak seals. Affected product must be destroyed. The letter included instructions on actions to take to be issued a credit. Customers should immediately check their stock for affected product and quarantine all units. Affected lots should be destroyed. When the recalling firm has received your completed destruction form, your account will be issued a credit, if applicable. If you have any questions, please contact 866-359-1704.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LRP
- Quantity affected
- 21,440 total
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-11-12
- Date posted
- 2024-12-23
- Location
- Northfield, IL
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