PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
FDA Device Recall #Z-1338-2018 — Class II — January 10, 2018
Recall Summary
| Recall Number | Z-1338-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 10, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ethicon, Inc. |
| Location | Somerville, NJ |
| Product Type | Devices |
| Quantity | 7020 |
Product Description
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Reason for Recall
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Distribution Pattern
Distribution US Nationwide, Canada, India, and Colombia.
Lot / Code Information
Product code: PDP346H GTIN: 10705031048126 Product lot: LL6459
Other Recalls from Ethicon, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0487-2025 | Class II | MONOCRYL" (poliglecaprone 25) Suture REF Y936H ... | Oct 8, 2024 |
| Z-0319-2025 | Class II | Coated VICRYL Polyglactin 910 Suture VIO 36IN(9... | Sep 25, 2024 |
| Z-2144-2024 | Class II | VICRYL (polyglactin 910) Suture - Indicated for... | May 10, 2024 |
| Z-2148-2024 | Class II | MONOCRYL (poliglecaprone 25) Suture - Intended ... | May 10, 2024 |
| Z-2147-2024 | Class II | PDS Plus Antibacterial (polydioxanone) Suture -... | May 10, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.