PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
This recall is currently active, issued April 3, 2025. It was issued by Ethicon Endo Surgery, Llc.
- Company
- Ethicon Endo Surgery, Llc
- Recall Initiated
- March 7, 2025
- Posted
- April 3, 2025
- Recall Number
- Z-1513-2025
- Quantity
- 792 units
- Firm Location
- Guaynabo, PR
- Official Source
- View on FDA website ↗
Reason for Recall
Identified curing issues with the silicone during the needles manufacturing process.
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.
Lot / Code Info
Product Code: PDP127H-14; GMDN: 47362; UDI-DI: 10705031047907; Lot number: 104M7E;
Root Cause
Process control
Action Taken
On March 7, 2025, "URGENT: MEDICAL DEVICE RECALL (REMOVAL)"letters dated March 7, 2025, were sent to customers. ACTION REQUIRED 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax 866-209-0985 or email ethicon8403@sedgwick.com to Sedgwick within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to immediately return all unused sutures subject to this recall that are in inventory no later than June 30, 2025, to Sedgwick. 5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. If you require any assistance with returning product, please contact Sedgwick at 866-737-4762 and reference Event # 8403. If you have additional questions regarding this communication or want to report any product complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.