Date Initiated by Firm | September 28, 2012 |
Date Posted | October 11, 2012 |
Recall Status1 |
Terminated 3 on February 19, 2013 |
Recall Number | Z-0055-2013 |
Recall Event ID |
63362 |
510(K)Number | K914299 |
Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
|
Product | 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and
DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655.
K914299.
Waste system. |
Code Information |
Part Number (Item #) AG8049-NS, Lot # 2528655. |
Recalling Firm/ Manufacturer |
ICU Medical, Inc. 951 Calle Amanecer San Clemente CA 92673-6212
|
For Additional Information Contact | 949-366-2183 |
Manufacturer Reason for Recall | ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip
chamber may have been included on a 20 drop macro drip set. |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | ICU Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated September 28, 2012 to its customer. The letter identified the product, problem, and actions to be taken by the customer. The customer has been instructed to inspect their inventory for the specific lot numbers, examine for the presence of a metal cannula, and certify destruction of any affected devices. The customer letter included a Verification Form to be completed and returned. Contact ICU
Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com" for questions regarding this notice. |
Quantity in Commerce | 60 |
Distribution | Nationwide distribution: Virginia only. |
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 = DQO
|