Z-1340-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 18, 2018
- Initiation Date
- January 10, 2018
- Termination Date
- April 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180
Product Description
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
Reason for Recall
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Distribution Pattern
Distribution US Nationwide, Canada, India, and Colombia.
Code Information
Product code: PDPB346 GTIN: 10705031048829 Product lot: LMM273