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U.S. Department of Health and Human Services

Class 2 Device Recall NeoPAP

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  Class 2 Device Recall NeoPAP see related information
Date Initiated by Firm December 27, 2005
Date Posted April 07, 2006
Recall Status1 Terminated 3 on March 22, 2007
Recall Number Z-0717-06
Recall Event ID 34390
510(K)Number K040862  
Product Classification Ventilator, continous, neonatal - Product Code CBK
Product NeoPAP Neonatal CPAP/Humidification System
(Ventilator, Continuous)
Code Information Lot codes: 3124050609-01, 3124050609-02, 3124050609-03, 3124050803-01, 3124050803-02, 3124050803-03, 3124050803-04, 3124050803-05, 3124050623-01, 5313050323-01, 5313050620-01, 5306050624-01, 5306050623-01, 5306050323-01, 4568050622-01, 4568050415-01, 3195050217-06, 3195050511-01, 3195050426-12, 3195050511-02, 3195050511-03, 3195050511-05, 3195050511-07, 3195050511-08, 3195050511-10, 3195050520-07, 3195050412-05, 3195050418-02, 3195050418-03, 3195050418-06, 3195050418-07, 3195050418-09, 3195050418-13, 3195050418-14, 3195050418-15, 3195050426-01, 3195050426-02, 3195050426-03, 3195050426-04, 3195050426-05, 3195050426-11, 3195050426-13, 3195050426-14, 3195050426-15, 3195050511-09, 3195050511-11, 3195050511-12, 3195050511-13, 3195050511-14, 3195050511-15, 3195050520-01, 3195050520-02, 3195050520-03, 3195050520-04, 3195050520-05, 3195050527-02, 3195050527-03, 3195050527-04, 3195050527-05, 3195050527-06, 3195050527-07, 3195050527-08, 3195050131-08, 3195050120-02, 3195050120-07, 3195050120-08, 3195050120-09, 3195050114-03, 3195050527-12, 3195050527-13, 3195050527-14, 3195050527-15, 3195050609-01, 3195050609-02, 3195050609-04, 3195050722-07, 3195050609-07, 3155050722-04, 3155050722-05, 3195050811-03, 3195050426-07, 3195050609-09, 3195050811-04
Recalling Firm/
Manufacturer		 Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668
For Additional Information Contact James Vetricek
724-387-4559
Manufacturer Reason
for Recall		 Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.
FDA Determined
Cause 2		 Other
Action Respironics contacted customers via tracked letter informing them to discontinue use of their NeoPAP system. Distributors were contacted via telephone and e-mail instructing them to contact their customers and instruct them to discontinue use of the NeoPAP system. The recalling firm issued a Customer Advisory Notice (CAN) dated 1/5/06 to all customers.
Quantity in Commerce 83 effected units were identified
Distribution The product was shipped to medical facilities in GA, IA, MA, MN, NJ, OK, PA, TX, and WI. The product was also shipped to Sweden, South Africia, Egypt, Greece, and Saudi Arbia.
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 = CBK and Original Applicant = CARADYNE, LTD.
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