American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and N...
FDA Device Recall #Z-1790-2016 — Class II — March 31, 2016
Recall Summary
| Recall Number | Z-1790-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 31, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | American Surgical Company |
| Location | Salem, MA |
| Product Type | Devices |
| Quantity | 338 boxes |
Product Description
American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Reason for Recall
Product packaging defective compromising sterility
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Lot / Code Information
Lot numbers: 2015/08 BZ 2015/10 AG 2015/09 AW 2015/10 CD 2015/11 AZ 2015/11 BT 2015/12 AY 2015/11 BH 2015/12 CO 2015/12 DD
Other Recalls from American Surgical Company
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1755-2016 | Class II | American Surgical Cotton Balls-Strung 1/2" Ref... | Mar 31, 2016 |
| Z-1808-2016 | Class II | American Surgical Policot 1/2" x 1/2" Ref Numb... | Mar 31, 2016 |
| Z-1750-2016 | Class II | American Surgical Ultracot 15 mm x 15 mm (Glass... | Mar 31, 2016 |
| Z-1769-2016 | Class II | American Surgical Ray-Cot 1/2" x 3" Ref Number... | Mar 31, 2016 |
| Z-1752-2016 | Class II | American Surgical Ultracot 70 mm x 10090 mm R... | Mar 31, 2016 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.