Z-0069-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- October 24, 2017
- Termination Date
- July 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 kits
Product Description
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Reason for Recall
Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
Distribution Pattern
US Distribution to the state of : SC
Code Information
Lot # 109138