The probes involved have been part of the Nellcor CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists o
FDA device recall Z-1414-04 · posted 2004-09-02 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett
- Reason for recall
- The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis.
- Action taken
- On 8/24/04 the firm issued letters via Fax to all its direct consignees, informing them of the affected product and providing instructions on the recall. The firm followed up with phone calls to all consignees completed by 8/25/04. The firm also issued a press release via Associated Press on 8/27/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 14,120 units
- Distribution
- The firm has distributed the sensors to 1 researcher in Europe, and 68 to direct customers (medical facilities) and 112 Field Sales Reps. Currently, there are no finished goods at the manufacturing si
- Date initiated
- 2004-08-24
- Date posted
- 2004-09-02
- Date terminated
- 2005-12-15
- Location
- Pleasanton, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAPNOPROBE SL, MODEL 2000 (K010795) | Optical Sensors, Inc. | 2001-04-11 |