Baxter Head Positioning Adapter May Loosen During Patient Positioning
Baxter Healthcare is recalling an Adapter for Head Positioning (Model 1739994) used on operating tables because it may become loose and unintentionally move during patient positioning.
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: The FDA has classified this as a Class II recall. Although no illnesses or injuries are reported in the source text, the hazard involves unintended movement of a head positioning device during patient positioning, which is a risk-of-harm medical device defect where injury has not yet been reported, placing it at the High severity level per the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling the Adapter for Head Positioning, Model/Catalog Number 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables. A total of 13 units have been distributed.
The adapter may become loose during patient positioning and unintentionally move when used with the specified component. This condition could affect safe patient positioning during surgical procedures.
The affected product was distributed worldwide, including to the US states of Minnesota, Maryland, and Pennsylvania, and to multiple countries including Canada, Japan, Germany, France, the United Kingdom, and many others. Specific serial numbers affected include 109931797, 109931798, 109931799, 109943588, 109943590, 109948550, 109964963, 109964964, 109964969, 109964970, 109964971, 109980700, and 110006694. The product code is 1739994 with UDI-DI: 00887761972780.
Healthcare facilities and end users who have received this product should contact Baxter Healthcare Corporation for instructions on remediation or replacement. Facilities using the affected adapter should stop use until receiving further guidance from the manufacturer.
The recalled product
- Product
- Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 13
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 (13)
- Lot Code: Product Code: 1739994 UDI-DI: 00887761972780 Serial Numbers: 109931797
- 109931798
- 109931799
- 109943588
- 109943590
- 109948550
- 109964963
- 109964964
- 109964969
- 109964970
- 109964971
- 109980700
- and 110006694
Distribution
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