Philips Microstream Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS These products are used with Philips Monitors for
FDA device recall Z-2247-2011 · posted 2011-05-26 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Fine plastic strands on inner surface of the infant/ neonatal airway adapter may become dislodged and inhaled by the patient.
- Action taken
- The firm, Philips, sent a Field Safety Notice titled "URGENT MEDICAL DEVICE RECALL" letter dated April 2011 to its customers. Customer notifications outside the US will be managed by Philips representatives in each affected geography. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify all products from affected lots; remove from inventory and dispose in accordance with local regulations (new products will be sent proactively to each affected customer). Direct accounts were instructed to notify additional customers to whom the product has been distributed. These customers are instructed to follow the instructions in the "Action to be taken by Customer/User" section of the Notice. Questions regarding the recall can be directed towards the customer's local Philips representative at 1-800-722-9377.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 25,400 units (1016 boxes)
- Distribution
- Worldwide distribution.
- Date initiated
- 2011-04-07
- Date posted
- 2011-05-26
- Date terminated
- 2013-03-14
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROSTREAM FILTERLINE ICU (K980327) | Oridion Medical , Ltd. | 1998-04-16 |