Medical Paracentesis Kit Recalled Over Sterilization Assurance Failure
504 paracentesis kits (Lot 2405102) are being recalled because the manufacturer cannot confirm that sterilization requirements were met during production.
What this means for you
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: FDA Class II medical device recall involving loss of sterilization assurance confirmation. No illnesses or injuries are reported. Per the rubric, recalls with theoretical hazards and no reported harm score at most 3 (High).
Plain-English summary
American Contract Systems, Inc. is recalling 504 units of the Paracentesis Thoracente, SLPT76H medical convenience kit (Lot 2405102, expiration date 05/10/2025). This is a Class II FDA medical device recall.
The company identified that a chart recorder in one of its controlled manufacturing environment areas became inoperable. This caused humidity readings in that area to fall outside acceptable specifications. Because of this equipment failure, the company is unable to confirm that the product sterilization assurance requirements were met for the affected kits.
The affected kits were distributed nationwide to medical facilities in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
Consumers and healthcare facilities with this lot number should discontinue use and contact American Contract Systems or the FDA for instructions on return or replacement procedures.
The recalled product
- Product
- Paracentesis Thoracente, SLPT76H; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterilization-assurance-failure
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 (3)
- UDI-DI: 00191072199065
- Lot: 2405102
- Exp: 05/10/2025
Distribution
Distributed nationwide across the United States.
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