Z-2095-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- May 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 365 units
Product Description
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
Reason for Recall
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Distribution Pattern
Nationwide and Australia, Canada, S. Korea, Singapore
Code Information
Lot Numbers: B5, B6, B9, C6, C7, D2, D6, E5, E9, F2, F3, F5, F8, G4, G5, G9, I3, I4, I7, I8, J2, J3, K4, K5, K7, K8, L2, L9, O2, Q0, R2, S2, U0, V2, W1