Recall Z-0833-2014 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Symmetry Medical/SSI
Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bot
| Date | Jan 27, 2014 (initiated Dec 5, 2013) |
| Status | Terminated |
| Reason | The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier. |
| Root cause | Process control |
| Action | The firm notified their consignees of the recall by letter and email on 12/02/2013 instructing customers not to use the containers until further notice from Symmetry Surgical. |
| Quantity | 2,991 units |
| Distribution | Worldwide Distribution - US (Nationwide) and PR; and Internationally to: Italy, Australia, Saudi Arabia, UK, China, Canada, Germany, New Zealand, Colombia, Korea, and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120117 | CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM Codman & Shurtleff, Inc., Apr 16, 2012 |