Recall Z-0534-2008 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
Ambu Incorporated
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
| Date | Dec 22, 2007 (initiated Aug 21, 2007) |
| Status | Terminated |
| Reason | Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration. |
| Root cause | 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 |
| Quantity | 197 total |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.