FDAFDA · Food and drugs·Recall number Z-1296-2020
Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Published February 26, 2020 · Recall initiated: December 18, 2019
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
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LLC
- Distributor
- US Nationwide distribution.
- Lot
- Lot - D7H0946X Expiration Date - 2022-08-31
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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