Recall Z-2545-2017— Medtronic
Class II · Terminated
Class II FDA medical device recall by Medtronic, initiated 2017-05-03, terminated 2019-07-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312. Reason: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material..
- Recalling firm
- Medtronic
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-03
- Terminated
- 2019-07-18
- Firm location
- North Haven, CT, United States
Product description
Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
Reason for recall
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Data sourced from openFDA. This site is unofficial and independent of the FDA.