Date Initiated by Firm | June 08, 2010 |
Date Posted | August 02, 2010 |
Recall Status1 |
Terminated 3 on May 07, 2012 |
Recall Number | Z-2159-2010 |
Recall Event ID |
56037 |
510(K)Number | K823451 |
Product Classification |
Cardiovascular Procedure Kit - Product Code DTR
|
Product | Terumo Cardiovascular Procedure Kit Custom
X-COATED MASTER PACK
P/N 72790 |
Code Information |
Lots: ME19, MF10 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 28 Howe St Ashland MA 01721-1305
|
For Additional Information Contact | SAME 800-283-7866 Ext. 7420 |
Manufacturer Reason for Recall | Vent port may be occluded and prevent delivery of fluid |
FDA Determined Cause 2 | Equipment maintenance |
Action | Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately. |
Quantity in Commerce | 58 packs |
Distribution | Distribution USA and Canada |
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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510(K) Database | 510(K)s with Product Code = DTR
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