West Pharmaceutical Recalls Vial2Bag Advanced Devices Due to Sterile Barrier Risk
West Pharmaceutical Services is recalling Vial2Bag Advanced 20mm Admixture Devices because heat exposure during shipping may have compromised the sterile barrier.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential breach of the sterile barrier due to packaging damage, which is a risk-of-harm product issue where injury has not yet been reported, fitting the criteria for a moderate severity score.
Plain-English summary
West Pharmaceutical Services AZ, Inc. is recalling the Vial2Bag Advanced 20mm Admixture Device, Model 6070030. The recall involves 129,600 units of the single-use fluid transfer device, which is used to reconstitute and transfer fluids from drug vials into IV bags. The device is provided as a sterile, non-pyrogenic product.
The recall was initiated due to packaging damage caused by heat exposure during shipping and transportation. This damage may have resulted in a breach of the sterile barrier, potentially compromising the sterility of the device. The affected lots are Lot # K188 and Lot # K194.
The devices were distributed by Progressive Medical Inc. (PMI) to hospitals in the United States. PMI is located in Missouri and distributed the impacted lots to end users in 31 states, including Alabama, Arizona, California, Florida, New York, and Texas. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the…
- Manufacturer
- West Pharmaceutical Services AZ, Inc.
- Affected units
- 129,600
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 (4)
- Lot Code: Recall Product 1: Product Code 6080030
- Lot# K188
- Lot# K194
- UDI (01)10850022888011(17)270430(10)K194\F(90)36098150\F(91)6070030
Distribution
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