Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu Internat
FDA device recall Z-0533-2008 · posted 2007-12-22 · Terminated
Recall details
- Recalling firm
- Ambu Incorporated
- Reason for recall
- Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- BYE
- Quantity affected
- 197 total
- Distribution
- Nationwide.
- Date initiated
- 2007-08-21
- Date posted
- 2007-12-22
- Date terminated
- 2008-06-16
- Location
- Glen Burnie, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VALVE, AMBU PEEP (K782152) | Narco Air-Shields | 1978-12-26 |