FDAFDA · Food and drugs·Recall number Z-2533-2018
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
Published August 1, 2018 · Recall initiated: June 8, 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
Products do not meet a tensile strength specification
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon, Inc.
- Distributor
- Japan
- Lot
- Lot Number:MCZ162
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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