B. Braun Medical Recalls Non-Vented Dispensing Pins Due to Packaging Tears
B. Braun Medical is recalling approximately 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the product label.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall addresses a packaging defect (tears in the blister paper) that affects the label, which aligns with the rubric criteria for packaging-only problems and cosmetic defects.
Plain-English summary
B. Braun Medical, Inc. is recalling approximately 11,000 units of Non-Vented Dispensing Pins with One-Way Valve and Luer Lock Ultrasite Valve. The recall was initiated after the company identified a potential for a tear in the outer blister packaging on a limited number of units. These tears have been identified in the blister package paper where the unit label writing is located.
The affected products are used for the aspiration of medication from inverted bags or semi-rigid containers and for the intravenous delivery of transferred medication. The device is not intended for direct infusion. The recall covers specific serial numbers and product catalog numbers 412023 and 412027.
The affected units were distributed nationwide in the United States and Puerto Rico. Consumers and healthcare facilities should stop using the affected products and contact B. Braun Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 11,000
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 (17)
- Serial Numbers: 61342856
- 61181826
- 61200666
- 61221679
- 61250908
- 61230098
- 61259709
- 61316886
- 61325854
- 61318424
- 61321589
- 61315864
- 61187901
- 61282829
- 61247686
- 61266076
- 61277092 Product Catalog Number: 412023 and 412027
Distribution
Part of a larger recall action
This product is one of 2 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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