Recall Z-1414-04 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Nellcor Puritan Bennett
The probes involved have been part of the Nellcor CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is in a sealed foil envelope. Each disposable probe is used only one time.
| Date | Sep 2, 2004 (initiated Aug 24, 2004) |
| Status | Terminated |
| Reason | The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 site. 655 cases of product were disposed of at the distribution facility due to product expiration. Th |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010795 | CAPNOPROBE SL, MODEL 2000 Optical Sensors, Inc., Apr 11, 2001 |