Date Initiated by Firm | August 14, 2014 |
Date Posted | October 06, 2014 |
Recall Status1 |
Terminated 3 on November 13, 2014 |
Recall Number | Z-0023-2015 |
Recall Event ID |
69249 |
510(K)Number | K142097 |
Product Classification |
Set, administration, intravascular - Product Code FPA
|
Product | Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE |
Code Information |
Model/Product Number: B30-102 Lot #416130 Exp. 12/2016 |
Recalling Firm/ Manufacturer |
Biomedix, Inc. 3895 W Vernal Pike Bloomington IN 47404-2533
|
For Additional Information Contact | Lindsay J. Brown 812-355-7000 |
Manufacturer Reason for Recall | Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure. |
FDA Determined Cause 2 | Process control |
Action | Biomedix sent an PRODUCT RECALL NOTIFICATION letter dated August 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Please contact us with the quantity remaining in inventory or available to be returned to our facility. All units returned to Biomedix will be replaced with the same SELEC-3 item or a similar design at no charge.
Please call (1-800-627-2765 ) for further questions. |
Quantity in Commerce | 2,928 |
Distribution | US Distribution including the states of OH, NC, and TX |
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.
|
510(K) Database | 510(K)s with Product Code = FPA
|