FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: RUMMELL, Medline Item No. ST006ST
- Recall number
- Z-0760-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- RUMMELL, Medline Item No. ST006ST
- Status
- Open, Classified
- Initiated
- 2024-11-12
- Posted
- 2024-12-23
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 21,440 total
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI: 10653160251224 (ea) 00653160251227 (case); Lot 2023111490
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRP
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28