Windstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
Windstone Medical Packaging is recalling 3,260 AMS Convenience Kits because the included sodium chloride bags may contain detached blue break-off parts.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (foreign material in a medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 3,260 units of the AMS Convenience Kit: DSAEK Pack - RX (Part Number AMS12394B). The recall is due to the possibility that the 0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags contained in the kits may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
The affected kits were distributed nationwide in the states of California, Georgia, and Washington. The recall covers specific lot numbers, including 241907, 241223, and 241034, among others.
Healthcare providers and consumers should stop using the affected kits and contact Windstone Medical Packaging for further instructions.
The recalled product
- Product
- AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Infusion Kits
- Hazard
- Affected units
- 3,260
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 (20)
- UDI-DI:B098AMS12394B0
- Lot Numbers: 241907
- 241223
- 241034
- 240904
- 240705
- 240633
- 240269
- 238361
- 238197
- 238146
- 238085
- 238084
- 238041
- 237957
- 237901
- 237843
- 237663
- 237444
- 237443
Distribution
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