Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured...
Symmetry Medical/SSI began a recall of Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small... on . FDA classified it as Class II and gives the reason as "The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0833-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Symmetry Surgical GmbH
- Product
- 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 Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8748, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Small 4 Latch, REF 50-8950, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Small 4 Latch, REF 50-8951, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Green Small 4 Latch, REF 50-8952, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Blue Small 4 Latch, REF 50-8953, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Red Small 4 Latch, REF 50-8954, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Black Small 4 Latch, REF 50-8955, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Medium Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8736, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8737, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8738, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8749, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8750, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8751, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Medium 4 Latch, REF 50-8956, 445mm x 279mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Medium 4 Latch, REF 50-8957, 445mm x 279mm, QTY: 1,
- Product code
- KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Reason for recall
- The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier.
- Root cause tag
- manufacturing process
- FDA 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 in commerce
- 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.
- Product codes and lots
- all lots
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0833-2014 | Class II | Terminated | Voluntary: Firm initiated |
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