Summary
The FDA issued a Class II for Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 by B Braun Medical Inc. Reason: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP..
Details
Source
Device Recall
External ID
Z-2134-2024
Action Date
2024-06-19
Status
Ongoing
Category
device
Product Description
Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
Lot/Code Info: Catalogue Number: 4894502; UDI/DI: 04022495101310; Lot/Batch: 20E01, 20E03, 21E07, 21E09, 19E10, 22E10, 22E11, 21E13, 20E19, 20E20, 19E21, 19E22, 20E22, 23E26, 20E27, 23E31, 19F12, 19F13, 19F15, 19G03, 19G04, 19G06, 19G09, 19G20, 19G21, 19G24, 19G25, 19G27, 19H23, 19H28, 19H30, 19I11, 19I21, 19I25, 19I26, 19K11, 19K16, 19K17, 19K24, 19K25, 19L12, 19L13, 19L15, 19L19, 19M12, 19M14, 19M17, 19M21, 19M24, 19M26, 20A30, 20A31, 20B15, 20B18, 20B19, 20B21, 20B26, 20B27, 20C14, 20C17, 20C18, 20D01, 20D02, 20D04, 20D14, 20D16, 20D17, 20D21, 20D29, 20F06, 20F10, 20F11, 20F12, 20F13, 20G21, 20G22, 20G23, 20G29, 20G31, 20H01, 20H05, 20H26, 20H27, 20H29, 20L27, 20L28, 20M03, 20M19, 20M23, 20M25, 20M26, 21A16, 21A19, 21B04, 21B06, 21B10, 21B18, 21B20, 21B25, 21C11, 21C13, 21C17, 21D07, 21D08, 21D10, 21D29, 21F19, 21F23, 21F24, 21F25, 21F26, 21F30, 21G08, 21G09, 21G10, 21G14, 21G17, 21G20, 21G21, 21H05, 21H06, 21H07, 21H26, 21H28, 21I04, 21I22, 21I26, 21K07, 21K09, 21K13, 21K29, 21K30, 21L16, 21L17, 21L18, 21L19, 21L20, 21L30, 21M02, 21M03, 21M11, 21M14, 22A08, 22A25, 22B25, 22B27, 22C02, 22C03, 22C25, 22C29, 22D14, 22D15, 22D19, 22D21, 22F02, 22F04, 22G14, 22G16, 22G21, 22G23, 22G29, 22H25, 22I01, 22I03, 22I08, 22I28, 22K01, 22K05, 22K16, 22K18, 22K19, 22K20, 22L01, 22L02, 22L15, 22L16, 22M06, 22M15, 22M17, 23A08, 23A11, 23A31, 23B01, 23B07, 23B25, 23B28, 23C16, 23C18, 23C21, 23D19, 23D22, 23D28, 23F07, 23F30, 23G07, 23G11, 23G29, 23H01, 23I05, 23I06, 23I07, 23I23, 23I26, 23I28, 23I29, 23K18, 23K19,
Quantity Affected: 1,157,640 units
Reason for Recall
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-17
Company
Breinigsville, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B Braun Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B Braun Medical Inc have FDA actions?
B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2134-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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