Ambulance cot may separate due to insufficient epoxy in assemblies
Stryker's Power-PRO 2 ambulance cots may separate at head or foot due to insufficient epoxy. Four affected units in NY and VA should be removed from service immediately.
What this means for you
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: This is a Class II medical device recall with a structural defect that could result in patient injury during loading, unloading, or transport. No illnesses or injuries have been reported. Severity is High per the rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling Power-PRO 2 ambulance cots (Model 650705550001). Four units have been identified with this defect.
The recalled cots may have insufficient volume of epoxy in the head section and foot assembly systems. This defect may result in separation of the head or foot from the cot, which could occur unexpectedly during loading, unloading, or patient transport.
The affected units, identified by specific serial numbers (2208002066, 2208002071, 2209001508, 2208001664), have been distributed in New York and Virginia.
If your facility operates one of the affected cots, remove it from service immediately. Contact Stryker Medical for replacement or repair instructions. Do not use the cot with patients until the defect has been corrected.
The recalled product
- Product
- Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Ambulance Cot
- Hazard
- structural-defect
- separation-risk
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 (4)
- GTIN: 07613327559118 Serial Numbers: 2208002066
- 2208002071
- 2209001508
- 2208001664
Distribution
Distributed nationwide across the United States.
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