The Recall Desk
LowFDA (Devices)·Z-1907-2016·Announced 2016-06-08

B. Braun Recalls Non-Vented Dispensing Pins Due to Packaging Tears

B. Braun Medical is recalling 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the device.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a tear in the outer blister packaging paper. There are no reports of injury, illness, or device failure, and the hazard is limited to packaging integrity, fitting the criteria for a low-severity packaging-only problem.

Plain-English summary

B. Braun Medical, Inc. is recalling 11,000 units of Non-Vented Dispensing Pins with Luer Lock Ultrasite Valve. The recall was initiated after the company identified a potential for tears in the outer blister packaging on a limited number of units. These tears are located in the blister package paper where the unit label writing is situated.

The affected devices are used for the aspiration of medication from inverted bags or semi-rigid containers and for the intravenous delivery of transferred medication. The devices are 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 providers should stop using the affected devices and contact B. Braun Medical, Inc. for further instructions or a replacement.

The recalled product

Product
Non-Vented Dispensing Pin with 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.
Category
Medical Device — Infusion/Aspiration
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

Distributed nationwide across the United States.

The notice also names 46 states specifically:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · B. Braun Medical, Inc.

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Same hazard · packaging defect

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