PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Reported: April 9, 2025 Initiated: March 7, 2025 #Z-1515-2025
Product Description
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Reason for Recall
Identified curing issues with the silicone during the needles manufacturing process.
Details
- Recalling Firm
- Ethicon Endo Surgery, LLC
- Units Affected
- 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.
- Location
- Guaynabo, PR
Frequently Asked Questions
What product was recalled? ▼
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM. Recalled by Ethicon Endo Surgery, LLC. Units affected: 37,080 units.
Why was this product recalled? ▼
Identified curing issues with the silicone during the needles manufacturing process.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2025. Severity: Moderate. Recall number: Z-1515-2025.
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