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.
Recall
- Recall Number
- Z-1414-04
- Event Number
- 29892
- Firm
- Nellcor Puritan Bennett
- FEI Number
- 2936999
- Product Code
- CCK
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 24, 2004
- Posted
- September 2, 2004
- Terminated
- December 15, 2005
- Address
- 4280 Hacienda Dr, Pleasanton, CA, 94588-2719
Description
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.
The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis.
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.
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. The firm estimates 442 cases (3,536 units) to be in distribution channels.
14,120 units