Surgical chest support device recalled for potential cracking at attachment
Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.
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 an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is structural and theoretical in nature, meeting the criteria for High severity as a risk-of-harm medical device with no injuries yet reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 1,010 units of the Allen Advance Chest Support with Pad (model A-71301), a medical device used in operating rooms.
The potential hazard is that the device may crack where the Chest Base Prone support attaches to the carbon fiber operating room table rail.
The affected devices were distributed worldwide, including throughout the United States and to 32 other countries. Healthcare facilities using these devices should contact Baxter Healthcare Corporation for information about replacements or further instructions. No injuries or incidents have been reported in connection with this recall.
The recalled product
- Product
- Allen Advance Chest Support with Pad
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- structural-defect
- device-failure
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 code A-71301
- GTIN Number: (01)00615521003159
- a. Lot Codes: 19-238
- 19-238
- 19-287
- 19-337
- 19-352
- 20-225
- 21-085
- 21-102
- 20-326
- 19-170
- 19-150
- 19-162
- 19-326
- 20-031
- 20-072
- 20-245
- 19-235
- 20-091
Distribution
Distributed nationwide across the United States.
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