Reported Nov 6, 2024 · Ongoing
Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030…
West Pharmaceutical Services AZ, 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: West Pharmaceutical Services AZ, Inc. · 7400 E Tierra Buena Ln Ste 101 · Scottsdale, AZ · 85260-1795
Is this the product you have?
- Brand NameVial2Bag Advanced¿
- Product NameVial2Bag Advanced¿ 20mm
- Admixture Device Model/Catalog Number6070030
- Software VersionNot
- applicable Product DescriptionThe Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 20mm Admixture Device for the device to meet its intended purpose
- ComponentNo
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 6080030Lot Code: Recall Product 1 608003010850022888011Lot# K188, UDI (01)10850022888011(17)270430(10)K188\F(90)36098150\F(91)6070030 Recall Product 2 — 10850022888011Lot# K194, UDI (01)10850022888011(17)270430(10)K194\F(90)36098150\F(91)6070030 - Amount recalled
- 129600
Where it was sold
Why it was recalled
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
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.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.