Oral thermometer probes recalled after being programmed with rectal configuration
Baxter is recalling 5,209 oral probes for Welch Allyn SureTemp Plus thermometers that were inadvertently programmed with the rectal probe configuration and may read low.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a probe reading lower than the true temperature can delay treatment of fever or infection, and no injuries are reported.
Plain-English summary
The Oral Probe, product code 02893-000, an accessory used with Welch Allyn SureTemp Plus 690 and 692 thermometers, is being recalled.
Affected oral and axillary probes were inadvertently programmed with the rectal probe configuration. The firm states affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
The recall covers 5,209 units, distributed nationwide in the United States and to Canada and Colombia. The FDA has classified the action as Class II.
The enforcement record describes the misconfiguration and reports no injuries. Facilities should identify affected probes and follow Baxter's instructions.
The recalled product
- Product
- Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Thermometer
- Affected units
- 5,209
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product code 01690-200
- Product code 01690-400
Distribution
Distributed nationwide across the United States.
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