U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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.
US Distribution including the states of OH, NC, and TX
제품 설명
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