Stimuplex A Injection Needles Recalled for DEHP Mislabeling
B Braun Medical Inc is recalling Stimuplex A injection needles because the devices are labeled as DEHP-free, but the glue used contains traces of DEHP. The recall affects 20,850 units distributed in the US and Canada.
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: FDA classified this as a Class II recall. The devices are labeled as DEHP-free but contain traces of DEHP in the glue, creating a mislabeling issue. DEHP is a chemical of concern in medical devices, making this a risk-of-harm product where composition discrepancy may affect vulnerable users.
Plain-English summary
B Braun Medical Inc is recalling Stimuplex A injection needles (Catalogue Number 4894251) in the following lot numbers: 20E15, 19L09, 19L27, 20A19, 20H21, 21G14, 21I16, and 22H23. The affected devices are 30-degree bevel, 24-gauge needles 1 inch in length.
The devices are labeled as "not made with DEHP" or display a DEHP-free symbol. However, the glue used in the devices contains traces of DEHP (di(2-ethylhexyl) phthalate). This labeling discrepancy means the products do not match their stated composition.
The recall affects 20,850 units distributed throughout the United States and Canada. Healthcare providers and facilities should identify and quarantine any remaining inventory of these specific lots.
The recalled product
- Product
- Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
- Manufacturer
- B Braun Medical Inc
- Affected units
- 20,850
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 (10)
- Catalogue Number: 4894251
- UDI/DI: 04022495101167
- Lot/Batch: 20E15
- 19L09
- 19L27
- 20A19
- 20H21
- 21G14
- 21I16
- 22H23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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