Date Initiated by Firm | January 07, 2011 |
Date Posted | July 12, 2011 |
Recall Status1 |
Terminated 3 on June 26, 2012 |
Recall Number | Z-2793-2011 |
Recall Event ID |
58979 |
510(K)Number | K021455 K031459 K031505 K031688 K031903 |
Product Classification |
Cardiovascular Guiding Catheter - Product Code DQY
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Product | Guidant RAPIDO Cut-Away Guiding Catheter, 6F.
Part Numbers: 66676-201 and 667552-100.
For use in cardiac diagnostic and therapeutic procedures. |
Code Information |
Lot Number: 0120891 and 0121091 |
Recalling Firm/ Manufacturer |
Abbott Vascular 26531 Ynez Rd Temecula CA 92591-4630
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For Additional Information Contact | Keith Krohn 951-914-3324 |
Manufacturer Reason for Recall | Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization. |
FDA Determined Cause 2 | Process control |
Action | Abbott Vascular sent an Urgent Device Recall letter, dated January 7, 2011, noting the products being recalled and the reasons for recall. The firm also provided the following reconciliation instructions to its territory manager:
-Help customer identify aflected product.
- CaIl Abbott Vascular Customer Service (800) 221-9902 to receive RGA number. Record RGA number below.
- Fax this completed form to (951) 914-3826.
- Return a copy of this completed form with the returned product |
Quantity in Commerce | 389 units total |
Distribution | Nationwide distribution, and Ireland. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = DQY 510(K)s with Product Code = DQY
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