Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
Reported: August 9, 2023 Initiated: May 15, 2023 #Z-2294-2023
Product Description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
Reason for Recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 192 kits
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 192 kits.
Why was this product recalled? ▼
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2294-2023.
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