Z-1567-2017 Class II Terminated
FDA device recall Z-1567-2017 was initiated by Resource Optimization & Innovation Llc on January 9, 2017 and is designated Class II. Reason for recall: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field. The recall status is terminated (terminated September 28, 2018). Affected quantity: 28 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- January 9, 2017
- Termination Date
- September 28, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 kits
Product Description
Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
Reason for Recall
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Distribution Pattern
US Distribution to LA and TX.
Code Information
031483A Exp Date 2017-02-27; 034832A Exp Date 2017-12-03;