Stimuplex A 30 DEG 22GX2 (B Braun) – DEHP Trace Glue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
Brand
B Braun Medical Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
B Braun Medical Inc is recalling Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 due to The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Recommended Action
Per FDA guidance
On May 17, 2024, URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Actions Required by B. Braun Medical Inc. (BBMI) Customer/User: 1. Review this notice in its entirety. Ensure that all users in your organization of the above-mentioned products, and other concerned personnel are informed about this voluntary correction. Post this notification where the affected products are stored. a. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The correction is to be extended to the consumer level. b. If you are a distributor that distributes partial cases, please ensure a copy of this notice is forwarded to your consignees. 2. Determine your current inventory. Review your inventory frequently to check these lot numbers. 3. Return the completed Urgent Medical Device Correction Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to recalls@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). For questions regarding the label and impacted Stimuplex A Needles, please call Customer Support at 1-800-227-2862. Adverse reactions or quality problems experienced with this product, or questions about this correction may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464. Adverse Reactions or quality problems in the United Sates may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026