FDAFDA · Food and drugs·Recall number Z-2542-2017
Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433
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
- MAXON 4/0 5X18" GREEN CV-24 D-TACH D4K0396X D4K2053X D4L0541X D4L1084X D4L1272X D4M0394X MAXON 5/0 5X18 GR CV-23 D-TACH D4K1485X MAXON* 4/0 5X30 GREEN V-20 D*TACH D4L1156GX
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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