ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an a...
FDA Device Recall #Z-0562-2015 — Class II — October 20, 2014
Recall Summary
| Recall Number | Z-0562-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 20, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pfm Medical Inc |
| Location | Carlsbad, CA |
| Product Type | Devices |
| Quantity | 1470 units |
Product Description
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Reason for Recall
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Lot / Code Information
Lot No. 1307-065, 1301-009
Other Recalls from Pfm Medical Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0561-2015 | Class II | ASEPT Pleural Drainage System, Pleural Drainage... | Oct 20, 2014 |
| Z-0564-2015 | Class II | 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D... | Oct 20, 2014 |
| Z-0565-2015 | Class II | ASEPT Peritoneal Drainage System, Ref No. P0908... | Oct 20, 2014 |
| Z-0563-2015 | Class II | Micro Introducer Kit, 5F Micro Introducer Kit, ... | Oct 20, 2014 |
| Z-0567-2015 | Class II | Veta Peritoneal Catheter Kit, Curled, Ref No. M... | Oct 20, 2014 |
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.