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U.S. Department of Health and Human Services

Class 2 Device Recall XIENCE Sierra TM RX 3.5mm x 33mm

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  Class 2 Device Recall XIENCE Sierra TM RX 3.5mm x 33mm see related information
Date Initiated by Firm March 25, 2020
Create Date June 15, 2020
Recall Status1 Terminated 3 on July 12, 2021
Recall Number Z-2370-2020
Recall Event ID 85497
Product Classification Coronary drug-eluting stent - Product Code NIQ
Product Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224A,
Code Information Lot Number: 903224A; Device Identifier/GTIN 08717648227455  
Recalling Firm/
Manufacturer		 Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact Alicia Swanson
408-845-3427
Manufacturer Reason
for Recall		 Incorrect expiration date
FDA Determined
Cause 2		 Incorrect or no expiration date
Action On March 25, 2020, the firm informed their customers that the firm has become aware that products were labeled with the incorrect expiration date. The firm sent an "Urgent Medical Device Recall" to customers. The recalled devices were shipped with a 36 months labeled expiration date, instead of 12 month expiration date. The firm is instructing customers to : - Review their inventory and immediately stop using devices from this lot - Complete and return the attached Effectiveness Check Form - Return all unused affected product to the firm. - Share this notification with other relevant personnel in their organization The firm requested customers to report any adverse reactions or quality problems to Customer Service Department at (800) 227-9902 and to return the "Effectiveness Check Form" to Customer Service Department at (800) 227-9902, scanned copy via E-mail to AVRegulatoryCompliance@av.abbott.com; return a copy of this form with the returned product.
Quantity in Commerce 13 units
Distribution US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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