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U.S. Department of Health and Human Services

Class 2 Device Recall Ambu PEEP valve

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  Class 2 Device Recall Ambu PEEP valve see related information
Date Initiated by Firm August 21, 2007
Date Posted December 22, 2007
Recall Status1 Terminated 3 on June 16, 2008
Recall Number Z-0535-2008
Recall Event ID 44734
Product Classification PEEP valve, ventilator accessory - Product Code BYE
Product Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
Code Information Catalog Number: A137001000, Lot Numbers:  030046, and  040056. 
Recalling Firm/
Manufacturer		 Ambu Incorporated
6740 Baymeadow Drive
Glen Burnie MD 21060-6412
For Additional Information Contact Sanjay Parikh
410-768-6464 Ext. 1136
Manufacturer Reason
for Recall		 Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
FDA Determined
Cause 2		 Process design
Action Ambu notified consignees with a letter dated 08/21/07 and flagged as Trouble Shooting Guide. The letter advised that some valves do not hold the set PEEP level under certain conditions and consignees were further advised to consider the guideline as an addendum to existing directions for use. Consignees were instructed to return (to Ambu) for replacement the identified lots listed in the notification and confirm receipt of the advisory by e-m or fax. Ambu subsequently identified additional lots of valves and replacement valve parts for recall and notified all consignees by "Urgent Device Recall" letter dated 11/29/07. The letter advised healthcare practitioners of the impact on patient treatment that may result in less than effective treatment. Consignees were further advised to cease use of the device and return for replacement.
Quantity in Commerce 197 total
Distribution Nationwide.
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.
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