American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Recall
- Recall Number
- Z-1763-2016
- Event Number
- 73734
- Firm
- American Surgical Company
- FEI Number
- 1221144
- Product Code
- EFQ
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- March 31, 2016
- Terminated
- October 21, 2016
- Address
- 45 Congress St, Salem, MA, 01970-5579
Description
American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Product packaging defective compromising sterility
American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: [email protected]
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.
4 boxes