Recall Z-1811-2016— American Surgical Company
Class II · Terminated
Class II FDA medical device recall by American Surgical Company, initiated 2016-03-31, terminated 2016-10-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges. Reason: Product packaging defective compromising sterility.
- Recalling firm
- American Surgical Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-31
- Terminated
- 2016-10-21
- Firm location
- Salem, MA, United States
Product description
Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Reason for recall
Product packaging defective compromising sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.