Midline Catheter Dressing Change Kit with Statlock recall: Sterility Concern
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change…
Why was Midline Catheter Dressing Change Kit with Statlock recalled?
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001
- Product
- Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change…
- Recalling firm
- Trinity Sterile, Inc.
- Quantity
- 2970 units
- Distribution
- US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
- Recall date
- April 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)