Home / Recalls / American Surgical Company / Z-1734-2016

Z-1734-2016 Class II Terminated

Recalled by American Surgical Company — Salem, MA

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
35 boxes

Product Description

American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW 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: 2015/11 AV 2015/12 BC

Other recalls by American Surgical Company

  • Z-1810-2016 Class II — American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neuros (March 31, 2016)
  • Z-1758-2016 Class II — American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: (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-1811-2016 Class II — Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neuros (March 31, 2016)
  • Z-1726-2016 Class II — American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage (March 31, 2016)
  • Z-1761-2016 Class II — American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: (March 31, 2016)
  • Z-1783-2016 Class II — American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Pr (March 31, 2016)
  • Z-1749-2016 Class II — American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product (March 31, 2016)
  • Z-1733-2016 Class II — American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage (March 31, 2016)
  • Z-1809-2016 Class II — American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neur (March 31, 2016)