Prolene BLU 18in(45cm) Usp6-0(m0.7) S/a P-1 PRM recall
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Why was Prolene BLU 18in(45cm) Usp6-0(m0.7) S/a P-1 PRM recalled?
Identified curing issues with the silicone during the needles manufacturing process.
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?
Product Code: (1) 8706H-15, (2) 8711H-16; GMDN: 13909; UDI-DI: (1) 10705031019430, (2) 10705031019560; Lot number: 104E88, 104E89, 1047TZ, 104BQ0, 104DA2, 104JAR, 104JPJ, 104SES, 104KHD, 104SER;
- Product
- PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
- Recalling firm
- Ethicon Endo Surgery, LLC
- Quantity
- 37,080 units
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.
- Recall date
- April 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)