ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
This recall is currently active, issued December 23, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- November 12, 2024
- Posted
- December 23, 2024
- Recall Number
- Z-0759-2025
- Quantity
- 21,440 total
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI: 10653160327141 (ea) 00653160327144 (case); Lot 2023021390
Root Cause
Process control
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.