Recall Z-1791-2016— American Surgical Company

Name: FDA recall Z-1791-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-31

Class II · Terminated

Class II FDA medical device recall by American Surgical Company, initiated 2016-03-31, terminated 2016-10-21. It names one FDA 510(k) clearance: K121822. Product: American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) 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

510(k) clearances named in this recall

1 on FDA's record

K121822 — DELICOTAmerican Surgical Company, LLC·cleared 2012-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) 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.