Preop Kit-NS surgical kits recalled for bacterial contamination
A M S Preop Kit-NS surgical convenience kits are being recalled due to contamination with Paenibacillus phoenicis bacteria discovered during sterilization testing. The kits were distributed nationwide in PA, GA, CA, and WA.
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: The FDA has classified this as a Class I recall. Per the rubric, FDA Class I recalls are classified as Severe (4) or Critical (5); since no deaths or serious injuries are reported in the source, the score is 4 (Severe).
Plain-English summary
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS surgical convenience kits (Pack Number AMS18227) manufactured by Windstone Medical Packaging, Inc. are being recalled. The kits contain Webcol Large Alcohol Prep Pads that were recalled by Cardinal Health after a contaminant, Paenibacillus phoenicis, was discovered during a routine sterilization dose audit.
Approximately 200 units were distributed nationwide across Pennsylvania, Georgia, California, and Washington. Affected lot codes include: 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.
Customers who have received these kits should stop using them immediately and contact Windstone Medical Packaging, Inc. or their distributor for instructions regarding return or replacement.
The recalled product
- Product
- A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kit
- 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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