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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Nellcor Puritan Bennett
Lot Codes / Batch Numbers
All lots of the CapnoProbe are under recall. Each unit has a code number printed on the packaging.
Products Sold
All lots of the CapnoProbe are under recall. Each unit has a code number printed on the packaging.
Nellcor Puritan Bennett is recalling The probes involved have been part of the Nellcor CapnoProbeTM SLS~1 Sublingual System. The CapnoPr due to The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026