FDAFDA · Food and drugs·Recall number Z-1340-2018
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
Published April 18, 2018 · Recall initiated: January 10, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon, Inc.
- Distributor
- Distribution US Nationwide, Canada, India, and Colombia.
- Lot
- Product code: PDPB346 GTIN: 10705031048829 Product lot: LMM273
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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