Sterile Procedural Trays recall
Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
Why was Sterile Procedural Trays recalled?
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
a. PELVISCOPY PACK, Item Number: DYNJ82555, Case UDI/GTIN: 40195327198252, Unit UDI/GTIN: 10195327198251, Lot Number: 22HBQ035; b. D-PELVISCOPY, Item Number: DYNJ900628I, Case UDI/GTIN: 40195327224142, Unit UDI/GTIN: 10195327224141, Lot Number: 22JDB340;
- Product
- Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 109 cases (316 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Recall date
- February 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)