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Recall Observatory FDA recall evidence

Device product

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

Z-2542-2017

May 03, 2017

Class II

Product summary

Firm
Medtronic
Event
Event 77144
Status
Terminated
Classification
Class II
Quantity
478,465 (total for all products)
Official record key
device-enforcement:Z-2542-2017

Official wording

Reason: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Code information: 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

Distribution pattern: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incomplete seal