Obstetric procedure kits recalled due to unconfirmed sterilization assurance
American Contract Systems is recalling 781 medical procedure kits because the manufacturer cannot confirm sterilization was properly completed. The affected kits were distributed to healthcare facilities in Illinois and Louisiana.
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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard—inability to confirm sterilization of obstetric procedure kits—represents a risk of harm but no actual patient harm has been documented. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
American Contract Systems Inc. is recalling 781 medical procedure kits due to inability to confirm proper sterilization. The recall affects two kit models: the Born on Arrival Kit (Model LLBN11C) and the Labor & Delivery Pack (Model LLLD19I).
During an internal investigation, American Contract Systems determined that the sterilization procedures for certain components within these kits were not properly justified. As a result, the company cannot confirm that sterilization assurance requirements were met. These kits are intended for use in medical procedures and rely on being properly sterilized.
The affected kits were distributed to healthcare facilities in Illinois and Louisiana. Consumers and healthcare providers should contact American Contract Systems for instructions on handling the affected units. Do not use these kits until the sterilization status has been verified.
The recalled product
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- infection-risk
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 (9)
- 1) Model/Item Number LLBN11C: UDI/DI 00191072233530
- Kit Lot Numbers: 70-051710
- 70-052354
- 2) Model/Item Number LLLD19I: UDI/DI 00191072233493
- Kit Lot Numbers: 70-051324
- 70-051967
- 70-053006
- 70-053303
- 70-053710.
Distribution
Distributed in 2 states:
- IL
- LA
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