Medical Device Swabs Recalled Due to Manufacturing Validation Uncertainty
Convenience kits containing Prevantics swabs used in medical procedures are being recalled because the manufacturer failed to adequately validate the manufacturing test methods used during production.
What this means for you
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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard involves manufacturing validation deficiency rather than direct contamination or structural defect, making it a precautionary recall that fits the profile for Moderate severity.
Plain-English summary
Windstone Medical Packaging is recalling convenience kits containing Prevantics swabs and swabsticks manufactured by Professional Disposables International. The affected kits are distributed under the Aligned Medical Solutions brand and include various procedure-specific packs used in medical settings, totaling 53,412 units.
The recall was initiated due to uncertainty regarding the adequacy of validation of the test methods used in the manufacturing process. This means the manufacturer did not sufficiently verify that testing procedures and manufacturing controls met required standards to ensure product safety and effectiveness.
The affected products were distributed to Pennsylvania, Washington, Florida, and Georgia. Specific lot codes for each product type have been identified and are available in the official recall notice from the FDA. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573,
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 53,412
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)
- AMS6569/ Between 142683 and 170329
- AMS6570B/ Between 150682 and 170330
- AMS6572A/Between 150863 and 170779
- AMS6573/Between 153041 and 167712
- AMS6828/Between 154460 and 165574
- AMS6828A/167575
- 168392
- AMS9954/Between 152386 and 157483
- AMS9954A/Between 157481 and 169200
- AMS10234/Between 152202 and 159363
- AMS10234A/Between 158104 and 169113
- AMS10236/Between 152782 and 156962
- AMS10236A/Between 157478 and 169198
- AMS10238/Between 150032 and 160155
- AMS10238A/Between 159664 and 166692
- AMS10238B/Between 167164 and 168646
- AMS10247/Between 146572 and 156705
- AMS10247A/Between 157182 and 168754
- AMS10249/Between 158599 and 161959
- AMS10249A/Between 157256 and 169105
Distribution
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