Reported Jun 8, 2016 · Terminated
Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of…
B. Braun Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B. Braun Medical, Inc. · 901 Marcon Blvd · Allentown, PA · 18109-9512
Is this the product you have?
- Non-Vented Dispensing Pin with One-Way Valve and
- Luer Lock Ultrasite Valve Product UsageUsed for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
- Lot codes and dates
- Serial Numbers
6134285661181826612006666122167961250908612300986125970961316886613258546131842461321589613158646118790161282829612476866126607661277092
- Product Catalog Number412023 and 412027
- Serial Numbers
- Amount recalled
- Approximately 11,000 units available in commercial channels
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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