FDAFDA · Food and drugs·Recall number Z-2547-2017
CUSTOM SUTURE PACK; Item Number: US1540 and US1614
Published June 21, 2017 · Recall initiated: May 3, 2017
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
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic
- Distributor
- Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
- Lot
- A5C1345X A5E0919X
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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