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U.S. Department of Health and Human Services

Class 2 Device Recall Biomedix SELEC3 I.V. Administration Set

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  Class 2 Device Recall Biomedix SELEC3 I.V. Administration Set see related information
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 and Original Applicant = BIOMEDIX, INC.
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