Travel and Disease – comprehensive information from the Center for Disease Control including travel vaccine recommendationsĬhild Passenger Safety – information from car seats to teen driversįood Safety and Foodborne Illness – information from the FDA Do not give ibuprofen (Motrin/Advil) to babies under 6 months or acetaminophen (Tylenol) to babies under 2 months without checking with your healthcare provider first. The Big Book of Symptoms, a book from the American Academy of PediatricsĪcetaminophen and ibuprofen dosing chart – It is most accurate to calculate doses based on weight.
Affinity pediatrics code#
Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.Health圜 is the American Academy of Pediatrics’ parent recourse website.Ī pediatric Symptom Checker from the American Academy of Pediatrics 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. Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina, South Africa and Singapore.ġ A record in this database is created when a firm initiates a correction or removal action. A Medtronic representative is available to facilitate the return of affected product. Update: Customer communication to the newly identified customer was initiated verbally on August 20,2013, with the customer letter delivery beginning AUG 27, 2013. If you have any questions please contact your Medtronic Sales representative or Lifeline Technical Services at 1-87. It identified the affected product, stated the issue with the 2 affected lot numbers and health risks, and asked that the affected devices be quarantined for return to Medtronic. The Urgent Medical Device letter referenced that the letter is in follow-up to the previous phone call. was mailed to customers on June 28, 2013. An Urgent Medical Device Recall letter, dated June 26, 2013. Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.Ĭustomer communication was initiated verbally on June 14, 2013, to the 4 affected customers to quarantine any un-used units. The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface. These devices are available both in an uncoated and a Carmeda coated option.
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The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery.
Affinity pediatrics update#
Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Class 2 Device Recall Affinity Pediatric Arterial Filterįilter, blood, cardiopulmonary bypass, arterial line - Product Code DTM