Agency classClass IIOur severity:High FDA (Devices)·Z-2109-2023·Announced 2023-07-19

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.

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: 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
Category: Medical Device — Surgical support equipment
Hazard: structural-defect
device-failure
Affected units: 1,010

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.

Same manufacturer · Baxter Healthcare Corporation

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