Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtroni
FDA device recall Z-0154-2014 · posted 2013-11-05 · Terminated
Recall details
- Recalling firm
- Medtronic Vascular, Inc.
- Reason for recall
- A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm.
- Action taken
- Urgent Medical Device Recall Letters were sent on October 7, 2013 via UPS 3-day service.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NIQ
- Quantity affected
- 201 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-10-07
- Date posted
- 2013-11-05
- Date terminated
- 2014-02-11
- Location
- Santa Rosa, CA
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