Z-2109-2023 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA device recall Z-2109-2023 was initiated by Baxter Healthcare Corporation on May 18, 2023 and is designated Class II. Reason for recall: Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail. The recall status is ongoing. Affected quantity: 1,010 units.

Recall details

Product Type
Devices
Report Date
Jul 19, 2023
Initiation Date
May 18, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,010 units

Product description

Allen Advance Chest Support with Pad

Reason for recall

Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Belgium, Croatia, Denmark, Egypt, France, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.

Code information

Product code A-71301; GTIN Number: (01)00615521003159; a. Lot Codes: 19-238, 19-238, 19-287, 19-337, 19-337, 19-352, 20-225, 21-085, 21-102, 21-102, 20-326, 19-170, 19-170, 19-150, 19-150, 19-162, 19-326, 20-031, 20-072, 20-245, 19-235, 20-091, 21-057, 19-352, 20-031, 20-044, 20-063, 20-245, 20-245, 20-259, 20-259, 21-109, 21-109, 20-064, 20-225, 21-014, 19-190, 19-326, 20-014, 20-014, 20-063, 20-259, 20-259, 21-085, 21-048, 19-287, 20-072, 19-295, 19-302, 21-085, 19-134, 19-179, 19-179, 19-235, 19-235, 20-014, 20-326, 20-343, 21-085, 19-150, 21-014, 20-357, 20-009, 20-042, 20-064, 21-109, 19-287, 19-287, 19-287, 19-288, 20-031, 20-043, 20-043, 20-063, 20-091, 20-225, 20-309, 20-318, 21-036, 21-036, 21-036, 21-036, 19-141, 19-150, 19-150, 19-150, 19-150, 19-162, 19-162, 19-150, 19-150, 19-157, 19-157, 19-161, 19-161, 19-179, 19-190, 19-190, 19-190, 19-190, 19-161, 19-190, 19-179, 19-179, 19-238, 19-238, 19-238, 19-238, 19-238, 19-235, 19-179, 19-179, 19-235, 19-235, 19-235, 19-179, 19-295, 19-295, 19-287, 19-287, 19-287, 19-344, 19-302, 19-344, 19-344, 19-302, 19-287, 19-179, 20-009, 19-288, 19-288, 19-288, 19-288, 19-288, 19-288, 19-288, 20-043, 20-035, 19-352, 20-044, 20-042, 20-064, 20-031, 20-063, 20-044, 20-014, 20-031, 20-042, 20-042, 20-042, 20-042, 20-225, 20-223, 20-245, 20-245, 20-245, 20-240, 20-259, 20-259, 20-318, 20-318, 20-259, 20-318, 20-326, 20-326, 20-309, 20-343, 20-357, 21-005, 21-005, 20-357, 21-005, 21-005, 21-014, 21-014, 20-357, 21-048, 21-048, 21-048, 21-057, 21-057, 21-057, 21-079, 21-079, 21-079, 21-109, 21-109, 21-109, 21-109, 21-109, 20-073, 21-102, 21-102, 19-219, 20-245, 20-290, 19-141, 19-141, 19-150, 19-150, 19-190, 19-235, 20-031, 20-042, 20-091, 20-245, 20-245, 19-141, 19-150, 19-157, 19-190, 19-190, 19-235, 19-235, 19-238, 19-238, 19-238, 19-287, 19-288, 19-295, 19-326, 20-009, 20-042, 20-063, 20-063, 20-072, 20-223, 20-223, 20-240, 20-240, 20-042, 20-309, 21-048; b. 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A481404, A481405

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2109-2023
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for Z-2109-2023. Report a data issue: hello@regdatalab.com.