symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C1385
FDA device recall Z-1011-2017 · posted 2017-01-11 · Terminated
Recall details
- Recalling firm
- Symmetry Surgical, Inc.
- Reason for recall
- Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.
- Action taken
- Siemens sent a Customer Safety Notice letter to customers. The letter identified the affected product problem and actions to be taken. Siemens Customer Service Engineer will contact customers to setup an appointment for installation of the new residual current monitor (RCM).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KCT
- Quantity affected
- 149 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2016-11-29
- Date posted
- 2017-01-11
- Date terminated
- 2017-08-20
- Location
- Antioch, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLASHPAK (K113776) | Symmetry Medical | 2012-08-08 |