Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
This recall is currently active, issued August 3, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- May 15, 2023
- Posted
- August 3, 2023
- Recall Number
- Z-2294-2023
- Quantity
- 192 kits
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Lot / Code Info
Model Number: DYNJ45158A, UPC Number: 088827750721, all lot numbers distributed from Medline between 04/01/2020 and 04/28/2023.
Root Cause
Nonconforming Material/Component
Action Taken
Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.