Gore Propaten Vascular Graft configured for Pediatric recall
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers…
Why was Gore Propaten Vascular Graft configured for Pediatric recalled?
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
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?
Serial Number for HPT060015A: 6185496PP001 and Serial Numbers for HPT060015: 6185502PP001, 6185502PP002, 6185502PP003, 6185502PP004, 6185502PP006, 6185502PP007, 6185502PP009, 6185502PP010, 6185503PP001, 6185503PP002, 6185503PP004, 6185503PP005, 6185503PP006, 6185503PP007, 6185503PP008, 6185503PP009, 6185503PP010
- Product
- Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers…
- Recalling firm
- W L Gore & Associates, Inc.
- Quantity
- N/A
- Distribution
- US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia
- Recall date
- August 25, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)