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Stimuplex recallZ-2132-2024 · B Braun Medical Inc · initiated May 17, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B Braun Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

FDA root cause category: Component design/selection

What the company is doing

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 [email protected] 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.

Recall details

Recall number
Z-2132-2024
Status
Open, Classified
Initiated by the company
May 17, 2024
Posted by the FDA
Jun 11, 2024
Recalling firm
B Braun Medical Inc
Quantity
1,783,991 units
Product code
BXN
FDA submissions
K860126
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Catalogue Number: 4894260; UDI/DI: 04022495101211; Lot/Batch: 22E07, 20E08, 20E09, 23E09, 23E10, 19E11, 23E11, 23E13, 19E14, 20E14, 19E15, 19E16, 23E17, 23E18, 23E20, 22E21, 21E25, 22E25, 22E27, 20E29, 19E30, 20E30, 19E31, 22E31, 19F04, 19F05, 19F07, 19F21, 19F22, 19F26, 19F27, 19F28, 19F29, 19G30, 19H01, 19H02, 19H07, 19H08, 19H31, 19I04, 19I06, 19I07, 19K01, 19K02, 19K04, 19K08, 19K09, 19K27, 19K30, 19L06, 19L07, 19M05, 19M07, 19M10, 20A09, 20A11, 20A15, 20A17, 20B05, 20B06, 20B08, 20C03, 20C04, 20C05, 20C07, 20C11, 20C12, 20C20, 20C25, 20C26, 20C27, 20D07, 20D08, 20D09, 20D22, 20D23, 20D24, 20D28, 20F02, 20F03, 20F05, 20F20, 20F23, 20F25, 20F26, 20F27, 20F30, 20G01, 20G09, 20G10, 20G14, 20G15, 20G16, 20G17, 20H06, 20H08, 20H18, 20H19, 20H20, 20I04, 20I09, 20I11, 20I12, 20I30, 20K02, 20K03, 20K10, 20K14, 20K16, 20L06, 20L07, 20L12, 20L14, 20L18, 20M09, 20M11, 20M12, 21A06, 21A08, 21A09, 21A13, 21A15, 21A21, 21A27, 21A28, 21A30, 21B16, 21B27, 21C03, 21C04, 21C06, 21C20, 21C24, 21C25, 21C27, 21C31, 21D15, 21D17, 21D20, 21F11, 21F12, 21F16, 21F17, 21G01, 21G02, 21G03, 21G07, 21G27, 21G28, 21G29, 21G31, 21H03, 21H11, 21H13, 21H20, 21I09, 21I11, 21I14, 21I15, 21I29, 21I30, 21K01, 21K02, 21K06, 21K15, 21K16, 21K20, 21K22, 21K23, 21K27, 21K28, 21L06, 21L07, 21L09, 21L10, 21L23, 21L25, 21L26, 21L27, 21M04, 21M07, 21M08, 21M09, 21M18, 21M21, 21M22, 21M24, 22A12, 22A14, 22A15, 22B04, 22B08, 22B09, 22B16, 22B17, 22C05, 22C09, 22C10, 22C12, 22D05, 22D07, 22D22, 22D26, 22D28, 22D29, 22F16, 22F18, 22F22, 22F24, 22G02, 22G06, 22G08, 22G12, 22H04, 22H06, 22H10, 22H11, 22H19, 22I10, 22I13, 22I15, 22I21, 22K06, 22K08, 22K12, 22K13, 22K14, 22K25, 22K26, 22K27, 22L06, 22L08, 22L09, 22L10, 22M08, 22M10, 22M13, 22M24, 22M28, 23A13, 23B15, 23B17, 23C07, 23C08, 23C10, 23C14, 23C31, 23D04, 23D05, 23D12, 23D14, 23F20, 23F22, 23F23, 23G12, 23G14, 23G19, 23G20, 23G22, 23G25, 23G26, 23H05, 23H09, 23H11, 23H18, 23H20, 23H23, 23H24, 23H25, 23I13, 23I14, 23I15, 23I16, 23I21, 23K05, 23K06, 23K11.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94637).

Sources and updates

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