Recall Z-0534-2008
Ambu Incorporated · initiated August 21, 2007
Product
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
Codes / lots: Catalog Number: A000138000, Lot Number: 010017.
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: Process design
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.
Details
- Recall number
- Z-0534-2008
- Initiated
- August 21, 2007
- Posted by FDA
- December 22, 2007
- Terminated
- June 16, 2008
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Quantity
- 197 total
- Distribution
- Nationwide.
- Recalling firm
- Ambu Incorporated, Glen Burnie, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0533-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | 08/21/2007Terminated |
| Z-0535-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | 08/21/2007Terminated |
| Z-0536-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | 08/21/2007Terminated |