Surgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
Windstone Medical Packaging is recalling AMS Dr. Lewin Pack surgical convenience kits (45 units) distributed nationwide because they contain Webcol alcohol prep pads contaminated with Paenibacillus phoenicis bacteria.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device with a bacterial contaminant (Paenibacillus phoenicis) in a sterile product used in surgical procedures. Class I recalls by definition warrant a severity score of at least 4 per the rubric.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling the AMS, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack surgical convenience kit (Pack Number AMS7200D) in lot codes 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, and 241313. A total of 45 units were distributed to healthcare facilities in Pennsylvania, Georgia, California, and Washington.
The recall was initiated after Cardinal Health, manufacturer of the Webcol Large Alcohol Prep Pads included in these kits, discovered the bacterial contaminant Paenibacillus phoenicis during a routine sterilization dose audit. The contaminated prep pads were distributed as part of the surgical convenience kits.
Healthcare providers and patients who have received or are in possession of affected kits should stop using the Webcol Large Alcohol Prep Pads contained within them. For questions or to report product-related problems, contact Windstone Medical Packaging, Inc. or the FDA.
The recalled product
- Product
- A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- bacterial-contamination
- paenibacillus-phoenicis
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 none
- Lot Codes: 237663
- 237901
- 237957
- 238041
- 238084
- 238085
- 238146
- 238197
- 238589
- 239157
- 239216
- 239286
- 239337
- 239386
- 239943
- 240269
- 240633
- 240705
- 240903
Distribution
Distributed nationwide across the United States.
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