Home / Recalls / American Surgical Company / Z-1805-2016

Z-1805-2016 Class II Terminated

Recalled by American Surgical Company — Salem, MA

FDA device recall Z-1805-2016 was initiated by American Surgical Company on March 31, 2016 and is designated Class II. Reason for recall: Product packaging defective compromising sterility The recall status is terminated (terminated October 21, 2016). Affected quantity: 10 boxes.

Recall Details

Product Type: Devices
Report Date: June 1, 2016
Initiation Date: March 31, 2016
Termination Date: October 21, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10 boxes

Product Description

American Surgical Telfa 1" x 1" Ref Number: 80-12 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.

Code Information

Lot numbers: 2015/08 CI 2015/12 CU

Other recalls by American Surgical Company

Z-1736-2016 Class II — American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neur (March 31, 2016)
Z-1781-2016 Class II — American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray (March 31, 2016)
Z-1798-2016 Class II — American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosur (March 31, 2016)
Z-1810-2016 Class II — American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neuros (March 31, 2016)
Z-1731-2016 Class II — American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: (March 31, 2016)
Z-1750-2016 Class II — American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product (March 31, 2016)
Z-1732-2016 Class II — American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: N (March 31, 2016)
Z-1795-2016 Class II — American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neuros (March 31, 2016)
Z-1785-2016 Class II — American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neuro (March 31, 2016)
Z-1758-2016 Class II — American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: (March 31, 2016)