Pediatric care bed KayserBett IDA recalled due to entrapment hazard
KayserBett IDA pediatric care beds are being recalled because the hand control can be operated by children, creating a risk of entrapment and serious injury or death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I and the source text explicitly mentions the risk of death.
Plain-English summary
KAYSERBETTEN GMBH & CO. KG is recalling the KayserBett IDA pediatric care bed. The recall involves 372 units distributed in the US and Canada.
If the hand control's adjustment functions are not locked with the provided key when a child is unattended, there is an increased risk that the child or others may operate the control. This could cause a person to become trapped under the bed frame or between the bed frame and the floor.
This entrapment hazard can lead to serious injuries or death. Users should ensure the hand control is locked with the provided key whenever the patient is unattended.
The recalled product
- Product
- Pediatric care bed; Product Designation: KayserBett IDA;
- Manufacturer
- KAYSERBETTEN GMBH & CO. KG
- Affected units
- 372
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 (20)
- Product Designation: KayserBett IDA
- UDI-DI: 426038961IDAGU
- Serial Number: 386
- 387
- 388
- 389
- 390
- 391
- 392
- 635
- 636
- 637
- 638
- 639
- 641
- 642
- 643
- 644
- 645
- 646
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · entrapment
See all →- Severe
- High
- Severe
- Severe
- Severe
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